Enabling Statute: Food
and Drugs Act
Medical Devices Regulations (SOR/98-282)

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Medical Devices Regulations

SOR/98-282

Registration May 7, 1998

FOOD AND DRUGS ACT

Medical Devices Regulations
P.C. 1998-783 May 7, 1998

His Excellency the Governor General in Council, on the
recommendation of the Minister of Health, pursuant to subsections 3(3),
30(1) and 37(1)aof the Food and Drugs Act, hereby
makes the annexed Medical Devices Regulations.a S.C.
1993, c. 34, s. 73

Medical Devices Regulations

INTERPRETATION

1. The definitions in this section apply in
these Regulations.

"Act" means the Food and Drugs
Act. ( Loi )

"active device" means a medical
device that depends for its operation on a source of energy other than
energy generated by the human body or gravity. A medical device that
transmits or withdraws energy or a substance to or from a patient without
substantially altering the energy or the substance is not an active
device. ( instrument actif )

"active diagnostic device" means
an active device that, whether used alone or in combination with another
medical device, is intended to supply information for the purpose of
detecting, monitoring or treating a physiological condition, state of
health, illness or congenital deformity. ( instrument
diagnostique actif )

"active therapeutic device" means
medical device, is intended to support, modify, replace or restore a
biological function or structure for the purpose of treating or mitigating
an illness or injury or a symptom of an illness or injury. (
instrument thérapeutique actif )

"bar code" means a unique bar
code in the symbology of the Universal Product Code (UPC), the Health
Industry Business Communications Council (HIBCC) or the European Article
Number (EAN), assigned to a medical device by the manufacturer. ( code à barres )

"body orifice" means a natural
opening or a permanent artificial opening in the body, such as a stoma.
( orifice du corps )

"central cardiovascular system"
means the heart, pericardium, pulmonary veins, pulmonary arteries,
cardiac veins, coronary arteries, common carotid arteries, cerebral
arteries, brachiocephalic artery, aorta, inferior and superior vena cava,
renal arteries, iliac arteries and femoral arteries. (
système cardiovasculaire central )

"central nervous system" means
the brain, meninges, spinal cord and cerebrospinal fluid. (
système nerveux central )

"closed-loop system" , in respect
of a medical device, means a system that enables the device to sense,
interpret and treat a medical condition without human intervention. ( système à boucle fermée )

"Commissioner of Patents" means
the Commissioner of Patents appointed under subsection 4(1) of the Patent
Act. ( commissaire aux brevets )

"control number" means a unique
series of letters, numbers or symbols, or any combination of these, that
is assigned to a medical device by the manufacturer and from which a
history of the manufacture, packaging, labelling and distribution of a
unit, lot or batch of the device can be determined. (
numéro de contrôle )

"custom-made device" means a
medical device, other than a mass-produced medical device, that

(a) is manufactured in accordance
with a health care professional’s written direction giving its design
characteristics;

(b) differs from medical devices
generally available for sale or from a dispenser; and

(c) is

(i) for the sole use of a particular
patient of that professional, or

(ii) for use by that professional to
meet special needs arising in the course of his or her practice. ( instrument fait sur mesure )

"dental material" [Repealed,
SOR/2002-190, s. 1]

"directions for use" , in respect
of a medical device, means full information as to the procedures
recommended for achieving the optimum performance of the device, and
includes cautions, warnings, contra-indications and possible adverse
effects. ( mode d’emploi )

"dispenser" means a person who is
a member of a professional governing body and who is entitled, by virtue
of their membership in that body, to manufacture or adapt a medical device
in accordance with a health care professional’s written directions in
order to meet the specific requirements of a patient. (
préparateur )

"General Council Decision" has
the meaning assigned by subsection 30(6) of the Act. (
décision du Conseil général )

"genetic testing" means the
analysis of DNA, RNA or chromosomes for purposes such as the prediction of
disease or vertical transmission risks, or monitoring, diagnosis or
prognosis. ( test génétique )

"health care facility" means a
facility that provides diagnostic or therapeutic services to patients. It
includes a group of such facilities that report to one common management
that has responsibility for the activities carried out in those
facilities. ( établissement de santé )

"health care professional" means
a person who is entitled under the laws of a province to provide health
services in the province. ( professionnel de la santé
)

"identifier" means a unique
series of letters or numbers or any combination of these or a bar code
that is assigned to a medical device by the manufacturer and that
identifies it and distinguishes it from similar devices. (
identificateur )

"implant" means a medical device
that is listed in Schedule 2. ( implant
)

"invasive device" means a medical
device that is intended to come into contact with the surface of the eye
or penetrate the body, either through a body orifice or through the body
surface. ( instrument effractif )

"in vitro
diagnostic device" or "IVDD" means a medical
device that is intended to be used in vitro
for the examination of specimens taken from the body. (
instrument diagnostique in vitro
ou IDIV )

"manufacturer" means a person who
sells a medical device under their own name, or under a trade-mark,
design, trade name or other name or mark owned or controlled by the
person, and who is responsible for designing, manufacturing, assembling,
processing, labelling, packaging, refurbishing or modifying the device, or
for assigning to it a purpose, whether those tasks are performed by that
person or on their behalf. ( fabricant )

"medical device" means a device
within the meaning of the Act, but does not include any device that is
intended for use in relation to animals. ( instrument
médical )

"medical device family" means a
group of medical devices that are made by the same manufacturer, that
differ only in shape, colour, flavour or size, that have the same design
and manufacturing process and that have the same intended use. ( famille d’instruments )

"medical device group" means a
medical device comprising a collection of medical devices, such as a
procedure pack or tray, that is sold under a single name. (
ensemble d’instruments )

"medical device group family"
means a collection of medical device groups that are made by the
same manufacturer, that have the same generic name specifying their
intended use, and that differ only in the number and combination of
products that comprise each group. ( famille d’ensembles
d’instruments )

"name of the device" , in respect
of a medical device, includes any information necessary for the user to
identify the device and to distinguish it from similar devices. ( nom de l’instrument )

"near patient in
vitro diagnostic device" or "near patient
IVDD" means an in vitro diagnostic
device that is intended for use outside a laboratory, for testing at home
or at the point of care, such as a pharmacy, a health care professional’s
office or the bedside. ( instrument diagnostique clinique
in vitro )

"objective evidence" means
information that can be proved true, based on facts obtained through
observation, measurement, testing or other means, as set out in the
definition "objective evidence" in section 2.19 of
International Organization for Standardization standard ISO 8402:1994,
Quality management and quality assurance - Vocabulary, as amended
from time to time. ( preuve tangible )

"person" includes a partnership
and an association. ( personne )

"qualified investigator" means a
person who is a member in good standing of a professional association of
persons entitled under the laws of a province to provide health care in
the province and who is designated, by the ethics committee of the health
care facility at which investigational testing is to be conducted, as the
person to conduct the testing. ( chercheur compétent
)

"quality management system certificate"
means a valid quality management system certificate described in
paragraph 32(2)(f), 3(j) or (4)(p), as applicable,
that is issued by a registrar recognized by the Minister under section
32.1. ( certificat de système de gestion de la
qualité )

"quality system certificate"
[Repealed, SOR/2006-197, s. 1]

"recall" , in respect of a
medical device that has been sold, means any action taken by the
manufacturer, importer or distributor of the device to recall or correct
the device, or to notify its owners and users of its defectiveness or
potential defectiveness, after becoming aware that the device

(a) may be hazardous to health;

(b) may fail to conform to any
claim made by the manufacturer or importer relating to its effectiveness,
benefits, performance characteristics or safety; or

(c) may not meet the requirements
of the Act or these Regulations. ( rappel )

"safety and effectiveness requirements"
means the safety and effectiveness requirements set out in sections
10 to 20. ( exigences en matière de sûreté et
d’efficacité )

"serious deterioration in the state of
health" means a life-threatening disease, disorder or abnormal
physical state, the permanent impairment of a body function or permanent
damage to a body structure, or a condition that necessitates an unexpected
medical or surgical intervention to prevent such a disease, disorder or
abnormal physical state or permanent impairment or damage. (
détérioration grave de l’état de santé )

"significant change" means a
change that could reasonably be expected to affect the safety or
effectiveness of a medical device. It includes a change to any of the
following:

(a) the manufacturing process,
facility or equipment;

(b) the manufacturing quality
control procedures, including the methods, tests or procedures used to
control the quality, purity and sterility of the device or of the
materials used in its manufacture;

(c) the design of the device,
including its performance characteristics, principles of operation and
specifications of materials, energy source, software or accessories; and

(d) the intended use of the device,
including any new or extended use, any addition or deletion of a
contra-indication for the device and any change to the period used to
establish its expiry date. ( modification importante
)

"surgical or dental instrument"
means a reusable medical device that is intended for surgical or
dental use, including cutting, drilling, sawing, scraping, clamping,
hammering, puncturing, dilating, retracting or clipping, without
connection to an active device. ( instrument chirurgical
ou dentaire )

"surgically invasive device"
means an invasive device that is intended to enter the body through
an artificially created opening that provides access to body structures
and fluids. ( instrument effractif chirurgical
)

"system" means a medical device
comprising a number of components or parts intended to be used together to
fulfil some or all of the device’s intended functions, and that is sold
under a single name. ( système )

"test kit" means an in vitro diagnostic device that consists of reagents
or articles, or any combination of these, and that is intended to be used
to conduct a specific test. ( trousse d’essai
)

"validation" means confirmation
by examination and the provision of objective evidence that the
requirements for a specific intended use have been fulfilled, as set out
in the definition "validation" in section 2.18 of
International Organization for Standardization standard ISO 8402:1994,
Quality management and quality assurance - Vocabulary, as amended
from time to time. ( validation )

SOR/2002-190, s. 1; SOR/2003-173, s. 1; SOR/2005-142, s. 1;
SOR/2006-197, s. 1.

APPLICATION

2. These Regulations apply to

(a) the sale and advertising for
sale of a medical device; and

(b) the importation of a medical
device for sale or for use on individuals, other than importation for
personal use.

3. (1) These Regulations also apply to an in vitro diagnostic product that is a drug or that
contains a drug, as if the product were an in
vitro diagnostic device.

(2) Subsection (1) does not apply to a drug listed
in Schedule E or F to the Act, in the schedule to Part G or J of the
Food and Drug Regulations, in the Schedules to the Controlled
Drugs and Substances Act, or in the schedule to the Narcotic
Control Regulations.

4. Only sections 26 to 31, 37, 70, 75, 80, 86
and 87 apply to a dispenser.

5. These Regulations do not apply to a medical
gas piping system that is assembled on site at a health care facility and
permanently built into the structure of the facility, if

(a) the system meets the
requirements of National Standard of Canada CAN/CSA-Z305.1,
Nonflammable Medical Gas Piping Systems, as amended from time to
time; and

(b) a certificate of compliance
with that standard has been issued by a testing agency that meets the
requirements of National Standard of Canada CAN/CSA-Z305.4,
Qualification Requirements for Agencies Testing Nonflammable Medical
Gas Piping Systems, as amended from time to time.

CLASSIFICATION OF MEDICAL DEVICES

6. Medical devices are classified into one of
Classes I to IV by means of the classification rules set out in Schedule
1, where Class I represents the lowest risk and Class IV represents the
highest risk.

7. If a medical device can be classified into
more than one class, the class representing the higher risk applies.

PART 1

GENERAL

Application

8. This Part applies to medical devices that
are not subject to Part 2 or 3.

Manufacturer’s Obligations

9. (1) A manufacturer shall ensure that the medical
device meets the safety and effectiveness requirements.

(2) A
manufacturer shall keep objective evidence to establish that the medical
device meets those requirements.

Safety and Effectiveness Requirements

10. A medical device shall be designed and
manufactured to be safe, and to this end the manufacturer shall, in
particular, take reasonable measures to

(a) identify the risks inherent in
the device;

(b) if the risks can be eliminated,
eliminate them;

(c) if the risks cannot be
eliminated,

(i) reduce the risks to the extent
possible,

(ii) provide for protection appropriate
to those risks, including the provision of alarms, and

(iii) provide, with the device,
information relative to the risks that remain; and

(d) minimize the hazard from
potential failures during the projected useful life of the device.

11. A medical device shall not, when used for
the medical conditions, purposes or uses for which it is manufactured,
sold or represented, adversely affect the health or safety of a patient,
user or other person, except to the extent that a possible adverse effect
of the device constitutes an acceptable risk when weighed against the
benefits to the patient and the risk is compatible with a high level of
protection of health and safety.

12. A medical device shall perform as intended
by the manufacturer and shall be effective for the medical conditions,
purposes and uses for which it is manufactured, sold or represented.

13. During the projected useful life of a
medical device, its characteristics and performance shall not deteriorate
under normal use to such a degree that the health or safety of a patient,
user or other person is adversely affected.

14. The characteristics and performance of a
medical device shall not be adversely affected by transport or conditions
of storage, taking into account the manufacturer’s instructions and
information for transport and storage.

15. Reasonable measures shall be taken to
ensure that every material used in the manufacture of a medical device
shall be compatible with every other material with which it interacts and
with material that may come into contact with it in normal use, and shall
not pose any undue risk to a patient, user or other person.

16. The design, manufacture and packaging of a
medical device shall minimize any risk to a patient, user or other person
from reasonably foreseeable hazards, including

(a) flammability or explosion;

(b) presence of a contaminant or
chemical or microbial residue;

(c) radiation;

(d) electrical, mechanical or
thermal hazards; and

(e) fluid leaking from or entering
into the device.

17. A medical device that is to be sold in a
sterile condition shall be manufactured and sterilized under appropriately
controlled conditions, and the sterilization method used shall be
validated.

18. A medical device that is part of a system
shall be compatible with every other component or part of the system with
which it interacts and shall not adversely affect the performance of that
system.

19. A medical device that performs a measuring
function shall be designed to perform that function within tolerance
limits that are appropriate for the medical conditions, purposes and uses
for which the device is manufactured, sold or represented.

20. If a medical device consists of or
contains software, the software shall be designed to perform as intended
by the manufacturer, and the performance of the software shall be
validated.

Labelling Requirements

21. (1) No person shall import or sell a medical device
unless the device has a label that sets out the following information:

(a) the name of the device;

(b) the name and address of the
manufacturer;

(c) the identifier of the device,
including the identifier of any medical device that is part of a system,
test kit, medical device group, medical device family or medical device
group family;

(d) in the case of a Class III or
IV device, the control number;

(e) if the contents are not readily
apparent, an indication of what the package contains, expressed in terms
appropriate to the device, such as the size, net weight, length, volume or
number of units;

(f) the word “Sterile”, if the
manufacturer intends the device to be sold in a sterile condition;

(g) the expiry date of the device,
if the device has one, to be determined by the manufacturer on the basis
of the component that has the shortest projected useful life;

(h) unless self-evident to the
intended user, the medical conditions, purposes and uses for which the
device is manufactured, sold or represented, including the performance
specifications of the device if those specifications are necessary for
proper use;

(i) the directions for use, unless
directions are not required for the device to be used safely and
effectively; and

(j) any special storage conditions
applicable to the device.

(2) The information required pursuant to subsection
(1) shall be expressed in a legible, permanent and prominent manner, in
terms that are easily understood by the intended user.

SOR/2002-190, s. 2.

22. (1) Subject to subsection (2), if a medical device
is intended to be sold to the general public, the information required by
subsection 21(1) shall

(a) be set out on the outside of
the package that contains the device; and

(b) be visible under normal
conditions of sale.

(2) Where a package that contains a medical device
is too small to display all the information in accordance with section 21,
the directions for use shall accompany the device but need not be set out
on the outside of the package or be visible under normal conditions of
sale.

23. (1) Subject to subsection (3), the information
required by subsection 21(1) shall, as a minimum, be in either English or
French.

(2)
Subject to subsection (3), where the directions for use are
supplied in only one official language at the time of sale, directions for
use in the other official language shall be made available by the
manufacturer as soon as possible at the request of the purchaser.

(3) In
respect of a medical device to be sold to the general public, the
information required by paragraphs 21(1)(a) and (e) to
(j) shall, as a minimum, be in both English and French.

SOR/2002-190, s. 3.

Contraceptive Devices — Advertising

24. (1) For the purposes of subsections 3(1) and (2) of
the Act and subject to section 27, a condom may be advertised and sold to
the general public for the purpose of preventing the transmission of
venereal disease if the advertisement and the label of the condom claim
only that the condom reduces the risk of transmitting venereal disease.

(2) For
the purpose of subsection 3(3) of the Act and subject to section 27,
contraceptive devices, other than intrauterine devices, may be advertised
to the general public by any means other than by the distribution of
samples of the devices door-to-door or through the mail.

SOR/2002-190, s. 4.

Class I Medical Devices

25. (1) If the Minister believes on reasonable grounds,
after reviewing a report or information brought to the Minister’s
attention, that a Class I medical device may not meet the safety and
effectiveness requirements, the Minister may request the manufacturer to
submit, on or before a specified day, information to enable him or her to
determine whether the device meets those requirements.

(2) The
Minister may direct the manufacturer to stop the sale of a Class I medical
device if

(a) the manufacturer does not
comply with a request made pursuant to subsection (1) by the day specified
in the request; or

(b) the Minister determines, on the
basis of the information submitted pursuant to subsection (1), that the
device does not meet the safety and effectiveness requirements.

(3) The
Minister may lift the direction to stop the sale if

(a) the manufacturer provides the
information requested;

(b) corrective action has been
taken to ensure that the medical device satisfies the safety and
effectiveness requirements; or

(c) the Minister’s determination
was unfounded.

Class II, III and IV Medical Devices

Prohibition

26. Subject to section 37, no person shall
import or sell a Class II, III or IV medical device unless the
manufacturer of the device holds a licence in respect of that device or,
if the medical device has been subjected to a change described in section
34, an amended medical device licence.

27. No person shall advertise a Class II, III
or IV medical device for the purpose of sale unless

(a) the manufacturer of the device
holds a licence in respect of that device or, if the device has been
subjected to a change described in section 34, an amended medical device
licence; or

(b) the advertisement is placed
only in a catalogue that includes a clear and visible warning that the
devices advertised in the catalogue may not have been licensed in
accordance with Canadian law.

Medical Devices Deemed Licensed

28. If a system is licensed, all of its
components or parts that are manufactured by the manufacturer of the
system are deemed, for the purposes of its importation, sale or
advertisement, to have been licensed.

29. If a test kit is licensed, all of its
reagents or articles that are manufactured by the manufacturer of the test
kit are deemed, for the purposes of its importation, sale or
advertisement, to have been licensed.

30. If a medical device or a medical device
group is licensed and forms part of a medical device family or a medical
device group family, as the case may be, all other medical devices or
medical device groups in the family are deemed to have been licensed.

31. (1) If all the medical devices that form part of a
medical device group are licensed, that medical device group is deemed to
have been licensed.

(2) If a medical device group is licensed, all the
medical devices that form part of the medical device group are deemed, for
the purposes of its importation, sale or advertisement, to have been
licensed.

Application for a Medical Device Licence

32. (1) An application for a medical device licence
shall be submitted to the Minister by the manufacturer of the medical
device in a format established by the Minister and shall contain the
following:

(a) the name of the device;

(b) the class of the device;

(c) the identifier of the device,
including the identifier of any medical device that is part of a system,
test kit, medical device group, medical device family or medical device
group family;

(d) the name and address of the
manufacturer as it appears on the device label; and

(e) the name and address of the
establishment where the device is being manufactured, if different from
the one referred to in paragraph (d).

(2) An
application for a Class II medical device licence shall contain, in
addition to the information and documents set out in subsection (1), the
following:

(a) a description of the medical
conditions, purposes and uses for which the device is manufactured, sold
or represented;

(b) a list of the standards
complied with in the manufacture of the device to satisfy the safety and
effectiveness requirements;

(c) an attestation by a senior
official of the manufacturer that the manufacturer has objective evidence
to establish that the device meets the safety and effectiveness
requirements;

(d) an attestation by a senior
official of the manufacturer that the device label meets the applicable
labelling requirements of these Regulations;

(e) in the case of a near patient
in vitro diagnostic device, an attestation by
a senior official of the manufacturer that investigational testing has
been conducted on the device using human subjects representative of the
intended users and under conditions similar to the conditions of use; and

(f) a copy of the quality
management system certificate certifying that the quality management
system under which the device is manufactured satisfies National Standard
of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management
systems — Requirements for regulatory purposes.

(3) An
application for a Class III medical device licence shall contain, in
addition to the information and documents set out in subsection (1), the
following:

(a) a description of the device and
of the materials used in its manufacture and packaging;

(b) a description of the features
of the device that permit it to be used for the medical conditions,
purposes and uses for which it is manufactured, sold or represented;

(c) a list of the countries other
than Canada where the device has been sold, the total number of units sold
in those countries, and a summary of any reported problems with the device
and any recalls of the device in those countries;

(d) a list of the standards
complied with in the design and manufacture of the device to satisfy the
safety and effectiveness requirements;

(e) in the case of a device to be
sold in a sterile condition, a description of the sterilization method
used;

(f) a summary of all studies on
which the manufacturer relies to ensure that the device meets the safety
and effectiveness requirements, and the conclusions drawn from those
studies by the manufacturer;

(g) a copy of the device label;

(h) in the case of a near patient
in vitro diagnostic device, a summary of
investigational testing conducted on the device using human subjects
representative of the intended users and under conditions similar to the
conditions of use;

(i) a bibliography of all published
reports dealing with the use, safety and effectiveness of the device; and

(j) a copy of the quality
management system certificate certifying that the quality management
system under which the device is designed and manufactured satisfies
National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices —
Quality management systems — Requirements for regulatory purposes.

(4) An
application for a Class IV medical device licence shall contain, in
addition to the information and documents set out in subsection (1), the
following:

(a) a description of the device and
of the materials used in its manufacture and packaging;

(b) a description of the features
of the device that permit it to be used for the medical conditions,
purposes and uses for which it is manufactured, sold or represented;

(c) a list of the countries other
than Canada where the device has been sold, the total number of units sold
in those countries, and a summary of any reported problems with the device
and any recalls of the device in those countries;

(d) a risk assessment comprising an
analysis and evaluation of the risks, and the risk reduction measures
adopted to satisfy the safety and effectiveness requirements;

(e) a quality plan setting out the
specific quality practices, resources and sequence of activities relevant
to the device;

(f) the specifications of the
materials used in the manufacture and packaging of the device;

(g) the manufacturing process of
the device;

(h) a list of the standards
complied with in the design and manufacture of the device to satisfy the
safety and effectiveness requirements;

(i) detailed information on all
studies on which the manufacturer relies to ensure that the device meets
the safety and effectiveness requirements, including

(i) pre-clinical and clinical studies,

(ii) process validation studies,

(iii) if appropriate, software
validation studies, and

(iv) literature studies;

(j) in the case of a medical device
other than an in vitro diagnostic device,
manufactured from or incorporating animal or human tissue or their
derivative, objective evidence of the biological safety of the device;

(k) in the case of a near patient
in vitro diagnostic device, detailed
information on investigational testing conducted on the device using human
subjects representative of the intended users and under conditions similar
to the conditions of use;

(l) a summary of the studies
referred to in paragraph (i) and the conclusions drawn from those
studies by the manufacturer;

(m) a summary of the
investigational testing referred to in paragraph (k) and the
conclusions drawn from that testing by the manufacturer;

(n) a bibliography of all published
reports dealing with the use, safety and effectiveness of the device;

(o) a copy of the device label; and

(p) a copy of the quality
management system certificate certifying that the quality management
system under which the device is designed and manufactured satisfies
National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices —
Quality management systems — Requirements for regulatory purposes.

SOR/2003-173, s. 2; SOR/2006-197, s. 2.

Quality Management System Certificate

32.1 The Minister shall recognize a person as
a registrar for the purpose of issuing quality management system
certificates if the person

(a) has sufficient training,
experience and technical knowledge in the design and manufacture of
medical devices and in the effective implementation of quality management
systems to determine whether a quality management system satisfies a
standard referred to in paragraph 32(2)(f), 3(j) or
4(p); and

(b) conducts quality management
system audits in accordance with the applicable guidelines and practices
established by the International Organization for Standardization.

SOR/2003-173, s. 3; SOR/2006-197, s. 3.

32.2 A quality management system certificate
is valid for the period, not exceeding three years, specified in it.

SOR/2003-173, s. 3; SOR/2006-197, s. 4.

32.3 A registrar shall notify the Minister in
writing within 15 days after suspending or cancelling a quality management
system certificate.

SOR/2003-173, s. 3; SOR/2006-197, s. 4.

32.4 A registrar shall notify the Minister in
writing within 15 days after the expiry of a quality management system
certificate if the certificate has not been renewed.

SOR/2003-173,
s. 3; SOR/2006-197, s. 4.

32.5. The Minister may cease to recognize a
person as a registrar if the person no longer meets the requirements of
section 32.1 or fails to comply with section 32.3 or 32.4.

SOR/2003-173, s. 3.

Foreign Manufacturers

33. (1) If an application for a medical device licence
is submitted by a manufacturer of a country other than Canada, the
information and documents described in subsections 32(2) to (4) need not
be submitted if

(a) the applicant is governed, in
that country, by a regulatory authority that is recognized by the
Minister; and

(b) the application is accompanied
by a certificate of compliance and a supporting summary report, issued by
a conformity assessment body of that country that is recognized by the
Minister, which certify that the medical device meets the safety and
effectiveness requirements.

(2) For the purposes of subsection (1), the
Minister may recognize a regulatory authority and a conformity assessment
body of a country other than Canada only if it has the ability to
determine whether the device meets the safety and effectiveness
requirements.

(3) The
Minister shall, on request, make available to any interested persons the
list of recognized regulatory authorities and conformity assessment bodies
of countries other than Canada.

Application for a Medical Device Licence Amendment

34. If the manufacturer proposes to make one
or more of the following changes, the manufacturer shall submit to the
Minister, in a format established by the Minister, an application for a
medical device licence amendment including the information and documents
set out in section 32 that are relevant to the change:

(a) in the case of a Class III or
IV medical device, a significant change;

(b) a change that would affect the
class of the device;

(c) a change in the name of the
manufacturer;

(d) a change in the name of the
device;

(e) a change in the identifier of
the device, including the identifier of any medical device that is part of
a system, test kit, medical device group, medical device family or medical
device group family;

(f) in the case of a Class II
medical device, a change in the medical conditions, purposes or uses for
which the device is manufactured, sold or represented.

Additional Information and Samples

35. (1) If the information and documents submitted in
respect of an application for a medical device licence or a medical device
licence amendment are insufficient to enable the Minister to determine
whether a medical device meets the safety and effectiveness requirements,
the Minister may request the manufacturer to submit, on or before a
specified day, additional information necessary for making the
determination.

(2) In the course of examining the application, the
Minister may require the applicant to provide samples of the medical
device.

Issuance

36. (1) If the Minister determines that a medical
device in respect of which an application is submitted meets the safety
and effectiveness requirements, the Minister shall

(a) issue to the manufacturer of
the device a medical device licence, in the case of an application for a
medical device licence; or

(b) amend the medical device
licence, in the case of an application for a medical device licence
amendment.

(2) The Minister may set out in a medical device
licence terms and conditions respecting

(a) the tests to be performed on a
device to ensure that it continues to meet the safety and effectiveness
requirements; and

(b) the requirement to submit the
results and protocols of any tests performed.

(3) The
Minister may amend the terms and conditions of the medical device licence
to take into account any new development with respect to the device.

(4) The
holder of the medical device licence shall comply with the terms and
conditions of the licence.

Lot of In Vitro
Diagnostic Devices

37. No person shall sell a medical device from
a lot of licensed in vitro diagnostic devices
in respect of which terms and conditions were set out in the licence
pursuant to section 36, unless

(a) the results and protocol of any
test performed on the device in accordance with those terms and conditions
have been provided to the Minister; and

(b) the Minister determines, on the
basis of the information received under paragraph (a), that the
device continues to meet the safety and effectiveness requirements.

Refusal to Issue

38. (1) The Minister may refuse to issue or amend a
medical device licence if

(a) the applicant does not comply
with these Regulations or any provisions of the Act relating to medical
devices;

(b) the applicant has made a false
or misleading statement in the application;

(c) the medical device does not
comply with the labelling requirements set out in sections 21 to 23; or

(d) the applicant has not complied
with a request for additional information or samples made pursuant to
section 35 by the day specified in the request.

(2) The
Minister shall refuse to issue or amend a medical device licence if the
medical device does not meet the safety and effectiveness requirements or
if the information or samples provided pursuant to section 35 are
insufficient to enable the Minister to determine whether the medical
device meets those requirements.

(3) If the Minister refuses to issue or amend a
medical device licence, the Minister shall

(a) notify the applicant in writing
of the reasons for the refusal; and

(b) give the applicant an
opportunity to be heard.

Additional Information

39. If the Minister believes on reasonable
grounds, after reviewing a report or information brought to the Minister’s
attention, that a licensed medical device may not meet the safety and
effectiveness requirements, the Minister may request the manufacturer to
submit, on or before a specified day, information or samples to enable the
Minister to determine whether the device meets those requirements.

Suspension

40. (1) Subject to subsection (3), the Minister may
suspend a medical device licence if the Minister has reasonable grounds to
believe that

(a) the licensee has contravened
these Regulations or any provision of the Act relating to medical devices;

(b) the licensee has made a false
or misleading statement in the application;

(c) the licensee has failed to
comply with the terms and conditions of the licence;

(d) the licensee has not complied
with a request for information or samples made pursuant to section 39 by
the day specified in the request, or the information or samples provided
are insufficient to enable the Minister to determine whether the medical
device meets the safety and effectiveness requirements;

(e) the medical device no longer
meets the safety and effectiveness requirements; or

(f) on the basis of information
obtained after the device was licensed, the quality management system
under which the device has been designed, in the case of a Class III or IV
device, or manufactured, assembled, processed, packaged, refurbished or
modified, in the case of a Class II, III or IV device, is inadequate to
ensure that the device meets its specifications.

(2) Before
suspending a medical device licence, the Minister shall consider

(a) the licensee’s history of
compliance with these Regulations and with the provisions of the Act
relating to medical devices; and

(b) the risk that allowing the
licence to continue to be in force would constitute for the health or
safety of patients, users or other persons.

(3) Subject to section 41, the Minister shall not
suspend a medical device licence until

(a) the Minister has sent the
licensee a written notice that sets out the reason for the proposed
suspension, any corrective action required to be taken and the time within
which it must be taken;

(b) if corrective action is
required, the time set out in the notice has passed without the action
having been taken; and

(c) the licensee has been given an
opportunity to be heard in respect of the suspension.

SOR/2006-197, s. 4.

41. (1) The Minister may suspend a medical device
licence without giving the licensee an opportunity to be heard if it is
necessary to do so to prevent injury to the health or safety of patients,
users or other persons, by giving the licensee a notice in writing that
states the reason for the suspension.

(2) A licensee may ask the Minister, in writing,
that the suspension be reconsidered.

(3) The Minister shall, within 45 days after the
date of receiving the request, provide the licensee with an opportunity to
be heard.

42. The Minister may reinstate a medical
device licence if the situation giving rise to the suspension has been
corrected or if the reason for the suspension was unfounded.

Obligation to Inform

43. (1) Every manufacturer of a licensed medical device
shall, annually before November 1 and in a form authorized by the
Minister, furnish the Minister with a statement signed by the manufacturer
or by a person authorized to sign on the manufacturer’s behalf

(a) confirming that all the
information and documents supplied by the manufacturer with respect to the
device are still correct; or

(b) describing any change to the
information and documents supplied by the manufacturer with respect to the
device, other than those to be submitted under section 34 or 43.1.

(2) If the
manufacturer fails to comply with subsection (1), the Minister may cancel
the medical device licence.

(3) If the holder of a medical device licence
discontinues the sale of the medical device in Canada, the licensee shall
inform the Minister within 30 days after the discontinuance, and the
licence shall be cancelled at the time that the Minister is informed.

SOR/2003-173, s. 4.

Obligation to Submit Certificate

43.1 Subject to section 34, if a new or
modified quality management system certificate is issued in respect of a
licensed medical device, the manufacturer of the device shall submit a
copy of the certificate to the Minister within 30 days after it is issued.

SOR/2003-173, s. 5; SOR/2006-197, s. 4.

Medical Devices to Be Sold for the Purposes of
Implementing the General Council Decision

Application

43.2 Sections 43.3 to 43.6 apply to a medical
device in respect of which a manufacturer has applied to the Commissioner
of Patents for an authorization under section 21.04 of the Patent Act for
the purposes of implementing the General Council Decision.

SOR/2005-142, s. 2.

Notices to Commissioner of Patents

43.3 The Minister shall notify the
manufacturer and the Commissioner of Patents for the purposes of paragraph
21.04(3)(b) of the Patent Act that the manufacturer's medical
device meets the requirements of the Act and these Regulations if

(a) the manufacturer holds a
medical device licence in respect of the device issued in accordance with
section 36;

(b) the Minister is satisfied that
the manufacturer and the device comply with the Act and these Regulations;

(c) the manufacturer has submitted
to the Minister a copy of the application filed by the manufacturer with
the Commissioner of Patents under section 21.04 of the Patent Act;

(d) the manufacturer has submitted
to the Minister information regarding the manner in which the mark
referred to in paragraph 43.5(1)(a) is applied to all permanent
components of the device; and

(e) the manufacturer has submitted
to the Minister a sample of the label for the device that includes the
information required by paragraph 43.5(1)(b).
SOR/2005-142, s.
2.

43.4 The Minister shall notify the
manufacturer and the Commissioner of Patents for the purposes of paragraph
21.13(b) of the Patent Act in the event that the Minister is
of the opinion that the manufacturer's medical device referred to in
section 43.2 has ceased to meet the requirements of the Act and these
Regulations.

SOR/2005-142, s. 2.

Marking and Labelling

43.5 (1) No person shall sell a medical device referred
to in section 43.2 unless

(a) the mark "XCL" is displayed on
all permanent components of the device; and

(b) the label of the device
displays the mark "XCL" followed by the control number referred to in
paragraph 21(1)(d) and the words "FOR EXPORT UNDER THE GENERAL
COUNCIL DECISION. NOT FOR SALE IN CANADA." or "POUR EXPORTATION AUX TERMES
DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.".

(2) The
information required by subsection (1) shall be expressed in a legible,
permanent and prominent manner.

SOR/2005-142, s. 2.

Notice to Minister

43.6 The manufacturer of a medical device
referred to in section 43.2 shall notify the Minister in writing not less
than 15 days prior to commencing the manufacture of the device.

SOR/2005-142, s. 2.

Establishment Licence

Prohibition

44. (1) No person shall import or sell a medical device
unless the person holds an establishment licence.

(2)
Subsection (1) does not apply to the importation or sale of a
medical device by

(a) a retailer;

(b) a health care facility;

(c) in the case of a Class II, III
or IV medical device, the manufacturer of the medical device; or

(d) in the case of a Class I
device, the manufacturer of the medical device, if the manufacturer
imports or distributes solely through a person who holds an establishment
licence.

Application

45. An application for an establishment
licence shall be submitted to the Minister in a format established by the
Minister and shall contain the following:

(a) the name and address of the
establishment;

(b) the name, title and telephone
number of the representative of the establishment to contact for any
information concerning the application;

(c) a statement as to whether the
activity of the establishment is importation or distribution, or both;

(d) the names and addresses of the
manufacturers of the devices that are being imported or distributed;

(e) for each manufacturer, the
medical specialities, selected from among the specialities established by
the Minister, in respect of which the devices are imported or distributed;

(f) for each manufacturer, the
classes of the devices that are being imported or distributed;

(g) an attestation by a senior
official of the establishment that the establishment has documented
procedures in place in respect of distribution records, complaint handling
and recalls;

(h) if the establishment imports
devices, an attestation by a senior official of the establishment that the
establishment has documented procedures in place in respect of mandatory
problem reporting;

(i) if the establishment imports or
distributes Class II, III or IV devices, an attestation by a senior
official of the establishment that the establishment has documented
procedures in place, where applicable, for handling, storage, delivery,
installation, corrective action and servicing in respect of those devices;
and

(j) the address of each building in
Canada where the procedures described in paragraphs (g) to
(i) are in place.

Issuance

46. (1) If the Minister determines that the application
for an establishment licence meets the requirements of section 45, the
Minister shall issue to the applicant a licence in respect of the
establishment.

(2) An establishment licence shall expire on
December 31 of each year.

Refusal

47. (1) The Minister may refuse to issue an
establishment licence if the applicant has made a false or misleading
statement in the application.

(2) The Minister shall refuse to issue an
establishment licence if the Minister has reasonable grounds to believe
that issuing such a licence would constitute a risk to the health or
safety of patients, users or other persons.

(3) If the Minister refuses to issue an
establishment licence, the Minister shall

(a) notify the applicant in writing
of the reasons for the refusal; and

(b) give the applicant an
opportunity to be heard.

Notification

48. If, following the issuance of an
establishment licence, there is a change to any of the information
submitted in accordance with paragraph 45(a) or (b), the
holder of the establishment licence shall submit the new information to
the Minister within 15 days of the change.

Suspension

49. (1) Subject to subsection (3), the Minister may
suspend an establishment licence if the Minister has reasonable grounds to
believe that

(a) the licensee has contravened
these Regulations or any provision of the Act relating to medical devices;

(b) the licensee has made a false
or misleading statement in the application; or

(c) failure to suspend the
establishment licence would constitute a risk to the health or safety of
patients, users or other persons.

(2) Before suspending an establishment licence, the
Minister shall consider

(a) the licensee’s history of
compliance with these Regulations and with the provisions of the Act
relating to medical devices; and

(b) the risk that allowing the
licence to continue to be in force would constitute for the health or
safety of patients, users or other persons.

(3)
Subject to section 50, the Minister shall not suspend an
establishment licence until

(a) the Minister has sent the
licensee a written notice that sets out the reason for the proposed
suspension, any corrective action required to be taken and the time within
which it must be taken;

(b) if corrective action is
required, the time set out in the notice has passed without the action
having been taken; and

(c) the licensee has been given an
opportunity to be heard in respect of the suspension.

50. (1) The Minister may suspend an establishment
licence without giving the licensee an opportunity to be heard if it is
necessary to do so to prevent injury to the health or safety of patients,
users or other persons, by giving the licensee a notice in writing that
states the reason for the suspension.

(2) A licensee may ask the Minister, in writing,
that the suspension be reconsidered.

(3) The Minister shall, within 45 days after the
date of receiving the request, provide the licensee with an opportunity to
be heard.

51. The Minister may reinstate an
establishment licence if the situation giving rise to the suspension has
been corrected or if the reason for the suspension was unfounded.

Distribution Records

52. (1) The manufacturer, importer and distributor of a
medical device shall each maintain a distribution record in respect of
each device.

(2)
Subsection (1) does not apply to

(a) a retailer; or

(b) a health care facility in
respect of a medical device that is distributed for use within that
facility.

53. The distribution record shall contain
sufficient information to permit complete and rapid withdrawal of the
medical device from the market.

54. (1) The distribution record maintained by a
manufacturer of an implant shall also contain a record of the information
received on the implant registration cards forwarded to the manufacturer
from a health care facility pursuant to section 67.

(2) The
manufacturer of an implant shall update the information referred to in
subsection (1) in accordance with any information received from the health
care facility or the patient.

55. The manufacturer, importer and distributor
shall retain the distribution record maintained in respect of a medical
device for the longer of

(a) the projected useful life of
the device, and

(b) two years after the date the
device is shipped.

56. Distribution records shall be maintained
in a manner that will allow their timely retrieval.

Complaint Handling

57. (1) The manufacturer, importer and distributor of a
medical device shall each maintain records of the following:

(a) reported problems relating to
the performance characteristics or safety of the device, including any
consumer complaints, received by the manufacturer, importer or distributor
after the device was first sold in Canada; and

(b) all actions taken by the
manufacturer, importer or distributor in response to the problems referred
to in paragraph (a).

(2) Subsection (1) does not apply to

(a) a retailer; or

(b) a health care facility in
respect of a medical device that is distributed for use within that
facility.

58. The manufacturer, importer and distributor
of a medical device shall each establish and implement documented
procedures that will enable the manufacturer, importer or distributor to
carry out

(a) an effective and timely
investigation of the problems referred to in paragraph 57(1)(a);
and

(b) an effective and timely recall
of the device.

Mandatory Problem Reporting

59. (1) Subject to subsection (2), the manufacturer and
the importer of a medical device shall each make a preliminary and a final
report to the Minister concerning any incident that comes to their
attention occurring inside or outside Canada and involving a device that
is sold in Canada and that

(a) is related to a failure of the
device or a deterioration in its effectiveness, or any inadequacy in its
labelling or in its the directions for use; and

(b) has led to the death or a
serious deterioration in the state of health of a patient, user or other
person, or could do so were it to recur.

(2) The requirement to report an incident that
occurs outside Canada does not apply unless the manufacturer has
indicated, to a regulatory agency of the country in which the incident
occurred, the manufacturer’s intention to take corrective action, or
unless the regulatory agency has required the manufacturer to take
corrective action.

60. (1) A preliminary report shall be submitted to the
Minister

(a) in respect of an incident that
occurs in Canada

(i) within 10 days after the
manufacturer or importer of a medical device becomes aware of an incident,
if the incident has led to the death or a serious deterioration in the
state of health of a patient, user or other person, or

(ii) within 30 days after the
manufacturer or importer of a medical device becomes aware of an incident,
if the incident has not led to the death or a serious deterioration in the
state of health of a patient, user or other person, but could do so were
it to recur; and

(b) in respect of an incident that
occurs outside Canada, as soon as possible after the manufacturer has
indicated, to the regulatory agency referred to in paragraph 59(2), the
manufacturer’s intention to take corrective action, or after the
regulatory agency has required the manufacturer to take corrective action.

(2) The
preliminary report shall contain the following information:

(a) the name of the device and its
identifier, including the identifier of any medical device that is part of
a system, test kit, medical device group, medical device family or medical
device group family;

(b) if the report is made by

(i) the manufacturer, the name and
address of that manufacturer and of any known importer, and the name,
title and telephone and facsimile numbers of a representative of the
manufacturer to contact for any information concerning the incident, or

(ii) the importer of the device, the
name and address of the importer and of the manufacturer, and the name,
title and telephone and facsimile numbers of a representative of the
importer to contact for any information concerning the incident;

(c) the date on which the incident
came to the attention of the manufacturer or importer;

(d) the details known in respect of
the incident, including the date on which the incident occurred and the
consequences for the patient, user or other person;

(e) the name, address and telephone
number, if known, of the person who reported the incident to the
manufacturer or importer;

(f) the identity of any other
medical devices or accessories involved in the incident, if known;

(g) the manufacturer’s or
importer’s preliminary comments with respect to the incident;

(h) the course of action, including
an investigation, that the manufacturer or importer proposes to follow in
respect of the incident and a timetable for carrying out any proposed
action and for submitting a final report; and

(i) a statement indicating whether
a previous report has been made to the Minister with respect to the device
and, if so, the date of the report.

61. (1) After the preliminary report is made in
accordance with section 60, a final report shall be submitted to the
Minister in accordance with the timetable established under paragraph
60(2)(h).

(2) The final report shall contain the following
information:

(a) a description of the incident,
including the number of persons who have experienced a serious
deterioration in the state of their health or who have died;

(b) a detailed explanation of the
cause of the incident and a justification for the actions taken in respect
of the incident; and

(c) any actions taken as a result
of the investigation, which may include

(i) increased post-market surveillance
of the device,

(ii) corrective and preventive action
respecting the design and manufacture of the device, and

(iii) recall of the device.

SOR/2002-190, s. 5.

61.1 (1) Despite subsection 59(1), the manufacturer of a
medical device may permit the importer of the device to prepare and submit
the preliminary and final reports on the manufacturer’s behalf if the
information that the manufacturer and importer must include is identical.

(2) The
manufacturer shall advise the Minister in writing if the manufacturer has
permitted the importer to prepare and submit the reports on the
manufacturer’s behalf.

SOR/2002-190, s. 5.

62. [Repealed, SOR/2002-190, s. 5]

Recall

63. Sections 64 and 65 do not apply to

(a) a retailer; or

(b) a health care facility in
respect of a medical device that is distributed for use within that
facility.

64. The manufacturer and the importer of a
medical device shall, on or before undertaking a recall of the device,
each provide the Minister with the following:

(a) the name of the device and its
identifier, including the identifier of any medical device that is part of
a system, test kit, medical device group, medical device family or medical
device group family;

(b) the name and address of the
manufacturer and importer, and the name and address of the establishment
where the device was manufactured, if different from that of the
manufacturer;

(c) the reason for the recall, the
nature of the defectiveness or possible defectiveness and the date on and
circumstances under which the defectiveness or possible defectiveness was
discovered;

(d) an evaluation of the risk
associated with the defectiveness or possible defectiveness;

(e) the number of affected units of
the device that the manufacturer or importer

(i) manufactured in Canada,

(ii) imported into Canada, and

(iii) sold in Canada;

(f) the period during which the
affected units of the device were distributed in Canada by the
manufacturer or importer;

(g) the name of each person to whom
the affected device was sold by the manufacturer or importer and the
number of units of the device sold to each person;

(h) a copy of any communication
issued with respect to the recall;

(i) the proposed strategy for
conducting the recall, including the date for beginning the recall,
information as to how and when the Minister will be informed of the
progress of the recall and the proposed date for its completion;

(j) the proposed action to prevent
a recurrence of the problem; and

(k) the name, title and telephone
number of the representative of the manufacturer or importer to contact
for any information concerning the recall.

65. The manufacturer and the importer of a
medical device shall, as soon as possible after the completion of a
recall, each report to the Minister

(a) the results of the recall; and

(b) the action taken to prevent a
recurrence of the problem.

65.1 (1) Despite sections 64 and 65, the manufacturer of
a medical device may permit the importer of the device to prepare and
submit, on the manufacturer’s behalf, the information and documents with
respect to the recall if the information and documents that the
manufacturer and importer must submit are identical.

(2) The
manufacturer shall advise the Minister in writing if the manufacturer has
permitted the importer to prepare and submit the information and documents
with respect to the recall on the manufacturer’s behalf.

SOR/2002-190, s. 6.

Implant Registration

66. (1) Subject to section 68, the manufacturer of an
implant shall provide, with the implant, two implant registration cards
that contain

(a) the name and address of the
manufacturer;

(b) the name and address of any
person designated by the manufacturer for the collection of implant
registration information;

(c) a notice advising the patient
that the purpose of the cards is to enable the manufacturer to notify the
patient of new information concerning the safety, effectiveness or
performance of the implant, and any required corrective action; and

(d) a statement advising the
patient to notify the manufacturer of any change of address.

(2) An
implant registration card shall be designed for the recording of the
following information:

(a) the name of the device, its
control number and its identifier, including the identifier of any medical
device that is part of a system, test kit, medical device group, medical
device family or medical device group family;

(b) the name and address of the
health care professional who carried out the implant procedure;

(c) the date on which the device
was implanted;

(d) the name and address of the
health care facility at which the implant procedure took place; and

(e) the patient’s name and address
or the identification number used by the health care facility to identify
the patient.

(3) The two implant registration cards referred to
in subsection (1) shall be printed in both official languages; however,
the manufacturer may choose to provide four cards, two in English and two
in French.

67. (1) Subject to subsection (2), a member of the
staff of the health care facility where an implant procedure takes place
shall, as soon as possible after the completion of the procedure, enter
the information required by subsection 66(2) on each implant registration
card, give one card to the implant patient and forward one card to the
manufacturer of the implant or the person designated pursuant to paragraph
66(1)(b).

(2) The patient’s name and address shall not be
entered on the implant registration card forwarded to the manufacturer or
person designated pursuant to paragraph 66(1)(b) except with the
patient’s written consent.

(3) The health care facility, the manufacturer or
the person designated pursuant to paragraph 66(1)(b) shall not
disclose the patient’s name or address, or any information that might
identify the patient, unless the disclosure is required by law.

68. (1) The manufacturer of an implant may apply in
writing to the Minister for authorization to use an implant registration
method other than the implant registration cards described in section 66.

(2) The
Minister shall authorize the use of the implant registration method
proposed in the application referred to in subsection (1) if the Minister
determines that the method will enable the manufacturer to achieve the
purpose set out in paragraph 66(1)(c) as effectively as the use of
implant registration cards.

(3) Where an authorization has been granted
pursuant to subsection (2), the manufacturer shall implement the
alternative implant registration method, and sections 66 and 67 shall
apply with such modifications as are necessary.

PART 2

CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED
OR SOLD FOR SPECIAL ACCESS

Application

69. (1) This Part applies to custom-made devices and
medical devices that are to be imported or sold for special access.

(2) In
this Part, "special access" means access to a medical
device for emergency use or if conventional therapies have failed, are
unavailable or are unsuitable.

General

70. No person shall import or sell a Class III
or IV custom-made device or a medical device for special access unless the
Minister has issued an authorization for its sale or importation.

Authorization

71. (1) If a health care professional wishes to obtain
a medical device referred to in section 70, the professional shall apply
to the Minister for an authorization that would permit the manufacturer or
importer of the device to sell, or to import and sell, the device to that
professional.

(2) The application shall contain the following:

(a) the name of the device, its
class and its identifier, including the identifier of any medical device
that is part of a system, test kit, medical device group, medical device
family or medical device group family;

(b) the number of units required;

(c) the name and address of the
manufacturer or importer;

(d) the name, title and telephone
number of the representative of the manufacturer or importer to contact
for any information concerning the device;

(e) the diagnosis, treatment or
prevention for which the device is required;

(f) a statement that sets out

(i) the reasons the device was chosen
for the diagnosis, treatment or prevention,

(ii) the risks and benefits that are
associated with its use, and

(iii) the reasons the diagnosis,
treatment or prevention could not be accomplished using a licensed device
that is available for sale in Canada;

(g) the name and address of each
health care facility at which the device is to be used by that
professional;

(h) the known safety and
effectiveness information in respect of the device;

(i) a written undertaking by the
health care professional that the professional will inform the patient for
whom the device is intended of the risks and benefits associated with its
use;

(j) the directions for use, unless
directions are not required for the device to be used safely and
effectively; and

(k) in the case of a custom-made
device, a copy of the health care professional’s written direction to the
manufacturer giving the design characteristics of the device.

72. (1) The Minister shall issue an authorization
referred to in subsection 71(1) to a manufacturer or importer if the
Minister determines that

(a) the benefits that may be
obtained by the patient through the use of the device outweigh the risks
associated with its use;

(b) the health or safety of
patients, users or other persons will not be unduly affected;

(c) a licensed device that would
adequately meet the requirements of the patient is not available in
Canada; and

(d) the authorization is not being
used by the manufacturer or importer to circumvent the requirements of
Part 1.

(2) The
authorization issued under subsection (1) shall specify

(a) the number of units of the
device authorized to be imported;

(b) the number of units of the
device authorized to be sold; and

(c) the name of the health care
professional to whom the manufacturer or importer may sell the device.

Additional Information

73. If the information and documents submitted
in respect of an application made pursuant to section 71 are insufficient
to enable the Minister to determine whether the conditions set out in
subsection 72(1) have been met, the manufacturer, importer or health care
professional shall, at the request of the Minister, submit any further
information relevant to the application that the Minister may request.

74. The Minister may, in respect of an
authorization that has been issued,

(a) request the manufacturer,
importer or health care professional to submit information in respect of
the device if the Minister believes on reasonable grounds, after reviewing
a report or information brought to the Minister’s attention, that the
device for which the authorization has been issued no longer meets the
conditions set out in subsection 72(1); and

(b) issue a written cancellation of
the authorization, giving reasons, if

(i) the Minister determines that the
conditions set out in subsection 72(1) are no longer met, or

(ii) the information referred to in
paragraph (a) has not been submitted.

Labelling

75. No person shall import or sell a medical
device in respect of which an authorization has been issued pursuant to
section 72, or a Class I or II custom-made device, unless the device has a
label that

(a) sets out the name of the
manufacturer;

(b) sets out the name of the
device; and

(c) specifies whether the device is
a custom-made device or is being imported or sold for special access.

Distribution Records

76. The manufacturer or importer of a medical
device in respect of which an authorization has been issued pursuant to
section 72 shall maintain a distribution record in respect of the device
in accordance with sections 52 to 56.

Reporting an Incident

77. The health care professional referred to
in subsection 71(1) shall, within 72 hours after the occurrence of an
incident described in section 59 involving a medical device for which an
authorization has been issued pursuant to section 72, report the incident
to the Minister and to the manufacturer or importer of the device, and
specify the nature of the incident and the circumstances surrounding it.

Implant Registration

78. Sections 66 to 68 apply in respect of an
implant that is imported or sold for special access.

SOR/2002-190,
s. 7.

PART 3

MEDICAL DEVICES FOR INVESTIGATIONAL TESTING INVOLVING
HUMAN SUBJECTS

Application

79. This Part applies to medical devices that
are to be imported or sold for investigational testing involving human
subjects.

General

80. (1) Subject to subsections (2) and (3), no person
shall import or sell a medical device for investigational testing.

(2) A
manufacturer or importer of a Class II, III or IV medical device may sell
the device to a qualified investigator for the purpose of conducting
investigational testing if the manufacturer or importer holds an
authorization issued under subsection 83(1) and possesses records that
contain all the information and documents required by section 81.

(3) A
manufacturer or importer of a Class I medical device may sell the device
to a qualified investigator for the purpose of conducting investigational
testing if the manufacturer or importer possesses records that contain all
the information and documents required by section 81.

Records

81. The records referred to in section 80
shall contain the following:

(a) the name, address and telephone
number of the manufacturer and the importer of the device;

(b) the name of the device, its
class and its identifier, including the identifier of any medical device
that is part of a system, test kit, medical device group, medical device
family or medical device group family;

(c) a description of the device and
of the materials used in its manufacture and packaging;

(d) a description of the features
of the device that permit it to be used for the medical conditions,
purposes and uses for which it is manufactured, sold or represented;

(e) a list of the countries other
than Canada where the device has been sold, the total number of units sold
in those countries, and a summary of any reported problems with the device
and any recalls of the device in those countries;

(f) a risk assessment comprising an
analysis and evaluation of the risks, and the risk reduction measures
adopted for the purposes of conducting investigational testing of the
device, including, as appropriate,

(i) the results of any previous
research, testing and studies conducted with respect to the device,

(ii) a description of the methods
currently used to diagnose or treat the medical condition in respect of
which the investigational testing is being proposed, and

(iii) information respecting any
cautions, warnings, contra-indications and possible adverse effects
associated with the use of the device;

(g) the names of all the qualified
investigators to whom the device is proposed to be sold and their
qualifications, including their training and experience;

(h) the name and address of each
institution at which the investigational testing is proposed to be
conducted and, in the case of a Class III or IV device, written approval
from the institution indicating that the investigational testing may be
carried out there;

(i) a protocol of the proposed
investigational testing, including the number of units of the device
proposed to be used for the testing, the hypothesis for and objective of
the testing, the period of time during which the testing will be carried
out and a copy of the patient consent form;

(j) a copy of the device label; and

(k) a written undertaking from each
qualified investigator to

(i) conduct the investigational testing
in accordance with the protocol provided by the manufacturer,

(ii) inform a patient who is to be
diagnosed or treated using the device of any risks and benefits associated
with its use, and obtain the patient’s written consent for its use,

(iii) not use the device or permit it
to be used for any purpose other than the investigational testing
specified in the protocol,

(iv) not permit the device to be used
by any other person except under the direction of the qualified
investigator, and

(v) in the event of an incident
described in section 59, report the incident and the circumstances
surrounding it to the Minister and to the manufacturer or importer of the
device within 72 hours after it comes to the attention of the qualified
investigator.

Authorization

82. An application for an authorization
referred to in subsection 80(2) shall be made in writing to the Minister
and shall contain

(a) in the case of a Class II
medical device or a Class III or IV in vitro
diagnostic device that is not used for patient management, not including a
near-patient in vitro diagnostic device, the
information set out in paragraphs 81(a), (b) and (h)
to (j); and

(b) in the case of a Class III or
IV medical device that is not covered by paragraph (a), the
information and documents set out in section 81.
SOR/2002-190, s. 8.

83. (1) The Minister shall issue an authorization
referred to in subsection 80(2) to a manufacturer or importer if the
Minister determines that

(a) the device can be used for
investigational testing without seriously endangering the life, health or
safety of patients, users or other persons;

(b) the investigational testing is
not contrary to the best interests of patients on whom the testing will be
conducted; and

(c) the objective of the testing
will be achieved.

(2) The authorization referred to subsection (1)
shall specify

(a) the name of any qualified
investigator to whom the device may be sold;

(b) the type of diagnosis or
treatment for which the device may be sold;

(c) the number of units of the
device that are authorized to be sold; and

(d) the protocol according to which
the investigational testing is to be conducted.

Additional Information

84. If the information and documents submitted
in respect of an application made pursuant to section 82 are insufficient
to enable the Minister to determine whether the conditions set out in
subsection 83(1) have been met, the manufacturer or importer shall, at the
request of the Minister, submit any further information relevant to the
application that the Minister may request.

85. (1) The Minister may, in respect of a medical
device in relation to which investigational testing is being conducted,
request the manufacturer or importer of the device to submit information
in respect of the testing if the Minister believes on reasonable grounds,
after reviewing a report or information brought to the Minister’s
attention, that one of the following conditions may exist:

(a) the testing seriously endangers
the life, health or safety of patients, users or other persons;

(b) the testing is contrary to the
best interests of patients on whom the testing is being conducted;

(c) the objective of the testing
will not be achieved;

(d) the qualified investigator who
is conducting the testing is not respecting the undertaking required by
paragraph 81(k); or

(e) the information submitted in
respect of the testing is false or misleading.

(2) If the
information requested pursuant to subsection (1) is not submitted, or if
it is submitted and the Minister determines after reviewing it that a
condition identified in that subsection exists, the Minister may, by
written notice giving reasons,

(a) in the case of a Class I
device, direct the manufacturer or importer of the device to stop selling
the device to any qualified investigator named in the notice; or

(b) in the case of a Class II, III
or IV device, cancel the authorization referred to in subsection 83(1), in
whole or in part.

Labelling

86. No person shall import or sell a medical
device for investigational testing unless the device has a label that sets
out

(a) the name of the manufacturer;

(b) the name of the device;

(c) the statements “Investigational
Device” and “Instrument de recherche”, or any other statement, in English
and French, that conveys that meaning;

(d) the statements “To Be Used by
Qualified Investigators Only” and “Réservé uniquement à l’usage de
chercheurs compétents”, or any other statement, in English and French,
that conveys that meaning; and

(e) in the case of an IVDD, the
statements “The performance specifications of this device have not been
established” and “Les spécifications de rendement de l’instrument n’ont
pas été établies”, or any other statement, in English and French, that
conveys that meaning.

Advertising

87. No person shall advertise a medical device
that is the subject of investigational testing unless

(a) that person holds an
authorization issued under subsection 83(1) to sell or import the device;
and

(b) the advertisement clearly
indicates that the device is the subject of investigational testing, and
the purpose of the investigational testing.

Other Requirements

88. The requirements set out in the following
provisions apply to medical devices to which this Part applies:

(a) sections 52 to 56 with respect
to distribution records;

(b) sections 57 and 58 with respect
to complaint handling;

(c) sections 59 to 61.1 with
respect to mandatory problem reporting;

(d) sections 63 to 65.1 with
respect to recalls; and

(e) sections 66 to 68 with respect
to implant registration.
SOR/2002-190, s. 9.

PART 4

EXPORT CERTIFICATES

89. (1) For the purposes of section 37 of the Act,
Schedule 3 sets out the form to be used for an export certificate for
medical devices.

(2) The export certificate shall be signed and
dated by

(a) where the exporter of the
device is a corporation,

(i) the exporter’s senior executive
officer in Canada,

(ii) the exporter’s senior regulatory
officer in Canada, or

(iii) the authorized agent of the
person referred to in subparagraph (i) or (ii); or

(b) where the exporter of the
device is an individual,

(i) the exporter, or

(ii) the exporter’s authorized agent.

90. No person shall sign an export certificate
that is false or misleading or that contains omissions that may affect its
accuracy and completeness.

91. The exporter of a device shall maintain,
at their principal place of business in Canada, records that contain the
completed export certificates and shall, when requested to do so by an
inspector, submit the export certificates for examination.

92. The exporter of a device shall retain the
export certificate for a period of not less than five years after the date
of export.

PART 5

TRANSITIONAL PROVISIONS, REPEAL AND COMING INTO FORCE

Transitional Provisions

93. For the purposes
of sections 94 and 95, "old regulations" means the
Medical Devices Regulations, C.R.C., c. 871, and "Director" has the meaning assigned to it by those
regulations.

94. (1) Subject to
subsection (2), if an application for a notice of compliance has been
submitted with respect to a medical device pursuant to Part V of the old
regulations but has not been processed by the Director as of June 30,
1998, an application for a medical device licence shall be made pursuant
to these Regulations.

(2) For the purposes of an application for a
medical device licence, the information and documents required by
paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to
have been submitted if a notice of compliance with respect to the device
had been issued under the old regulations.

95. (1) A medical
device that, on June 30, 1998, is being sold in Canada pursuant to the old
regulations is not required to be licensed until February 1, 1999, if,

(a) in the case of a device that is
subject to Part V of the old regulations, the manufacturer

(i) has a notice of compliance in
respect of the device that is in effect on June 30, 1998, or

(ii) does not have a notice of
compliance in respect of the device that is in effect on June 30, 1998,
but has met, during the period beginning on October 8, 1982, and ending on
March 31, 1983, the requirements for device notification pursuant to Part
II of the old regulations in respect of the device; and

(b) in the case of a device that is
not subject to Part V of the old regulations, the manufacturer has, by
June 30, 1998, furnished the Director with the notification required in
subsection 24(1) of the old regulations in respect of the device.

(2) If an
initial application for licensing of a medical device that is referred to
in subsection (1) is submitted before February 1, 1999, the information
and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or
(4)(a) to (o) are deemed to have been submitted if

(a) in the case of a device that is
subject to Part V of the old regulations, the manufacturer

(i) has a notice of compliance in
respect of the device that is in effect on June 30, 1998, or

(ii) does not have a notice of
compliance that is in effect on June 30, 1998, in respect of the device,
but has met, during the period beginning on October 8, 1982, and ending on
March 31, 1983, the requirements for device notification pursuant to Part
II of the old regulations in respect of the device;

(b) in the case of a device that is
not subject to Part V of the old regulations, the manufacturer has, by
June 30, 1998, furnished the Director with the notification required in
subsection 24(1) of the old regulations in respect of the device.

(3)
Subsections (1) and (2) cease to apply in respect of a medical
device if a change described in section 34 is made in respect of the
device or if the notice of compliance is suspended or cancelled under
section 40 of the old regulations.

(4) For the purposes of this section, a notice of
compliance may be suspended or cancelled under section 40 of the old
regulations as if that section were still in force.

Repeal

96. The Medical Devices
Regulations1 are repealed.

1
C.R.C., c. 871

Coming into Force

97. (1) Subject to
subsections (2) to (5), these Regulations come into force on July 1, 1998.

(2)
Section 32, except paragraphs (2)(f), (3)(j) and
(4)(p), comes into force

(a) in the case of a medical device
referred to in section 94 or 95, on September 1, 1998;

(b) in the case of any other
medical device, on July 1, 1998.

(3) Paragraphs 32(2)(f), (3)(j) and
(4)(p) come into force on January 1, 2003.

(4)
Sections 43 and 44 come into force on January 1, 1999.

(5)
Sections 45 to 51 come into force on November 1, 1998.

SOR/2001-217, s. 1.

SCHEDULE 1

(Section 6)

CLASSIFICATION RULES FOR MEDICAL DEVICES
PART 1
MEDICAL DEVICES OTHER THAN IN
VITRO DIAGNOSTIC DEVICES

Invasive
Devices

Rule 1:

(1) Subject to
subrules (2) and (3), all surgically invasive devices are classified as
Class II.

(2) A surgically invasive
device that is intended to diagnose, monitor, control or correct a defect
of the central cardiovascular system or the central nervous system or of a
fetus in utero is classified as Class IV.

(3) A surgically invasive
device that is intended to be absorbed by the body, or that is normally
intended to remain in the body for at least 30 consecutive days, is
classified as Class III.

Rule 2:

(1) Subject to subrules
(2) to (4), all invasive devices that penetrate the body through a body
orifice or that come into contact with the surface of the eye are
classified as Class II.

(2) A device described in
subrule (1) that is intended to be placed in the oral or nasal cavities as
far as the pharynx or in the ear canal up to the ear drum is classified as
Class I.

(3) A device described in
subrule (1) that is normally intended to remain in the body or in contact
with the surface of the eye for at least 30 consecutive days is classified
as Class III.

(4) A device described in
subrule (1) that is intended to be represented as preventing the
transmission of infectious agents during sexual activities or reducing the
risk thereof is classified as Class III.

Rule
3:

Despite rules 1 and 2

(a) all denture
materials and orthodontic appliances, and their accessories, are
classified as Class II;

(b) all surgical or
dental instruments are classified as Class I; and

(c) all latex
condoms are classified as Class II.

Non-invasive
Devices

Rule 4:

(1) Subject to subrule
(2), all non-invasive devices that are intended to come into contact with
injured skin are classified as Class II.

(2) A device described in
subrule (1) that is intended to be used as a mechanical barrier, for
compression or for absorption of exudations, is classified as Class I.

Rule 5:

A non-invasive device
intended for channelling or storing gases, liquids, tissues or body fluids
for the purpose of introduction into the body by means of infusion or
other means of administration is classified as Class II.

Rule 6:

(1) Subject to subrules
(2) and (3), a non-invasive device intended for modifying the biological
or chemical composition of blood or other body fluids, or liquids, for the
purpose of introduction into the body by means of infusion or other means
of administration is classified as Class III.

(2) A device described in
subrule (1) whose characteristics are such that the modification process
may introduce a foreign substance into the body that is potentially
hazardous, taking into account the nature and quantity of the substance,
is classified as Class IV.

(3) A device described in
subrule (1) that accomplishes the modification by centrifugation, gravity
filtration or the exchange of gas or heat is classified as Class II.

Rule 7:

(1) Subject to subrule
(2), all other non-invasive devices are classified as Class I.

(2) A device described in
subrule (1) is classified as Class II if it is intended

(a) to act as a calibrator, tester or quality
control support to another medical device; or

(b) to be connected to an active device that is
classified as Class II, III or IV.

Active
Devices

Rule 8:

(1) Subject to subrules
(2) and (3), an active device intended to emit ionizing radiation,
including any device or software intended to control or monitor such a
device or directly influence its performance, is classified as Class III.

(2) A device described in
subrule (1) that is intended to be used in radiographic mode is classified
as Class II.

(3) Despite subrule (2),
an active device that is intended to be used for mammographies is
classified as Class III.

Rule 9:

(1) Subject to subrules
(2) and (3), an active therapeutic device, including any dedicated
software, intended to be used to administer or withdraw energy to or from
the body is classified as Class II.

(2) If the administration
or withdrawal by a device described in subrule (1) is potentially
hazardous, taking into account the nature of the administration or
withdrawal, the intensity of the energy and the part of the body
concerned, the device is classified as Class III.

(3) A device described in
subrule (2) that is intended to control the treatment of a patient’s
condition through a closed loop system is classified as Class IV.

Rule 10:

(1) Subject to subrule
(2), an active diagnostic device, including any dedicated software, that
supplies energy for the purpose of imaging or monitoring physiological
processes is classified as Class II.

(2) A device described in
subrule (1) that is intended to be used to monitor, assess or diagnose a
disease, a disorder, an abnormal physical state or a pregnancy, if
erroneous readings could result in immediate danger, is classified as
Class III.

Rule 11:

(1) Subject to subrules
(2) and (3), an active device, including any dedicated software, intended
to administer drugs, body fluids or other substances to the body or
withdraw them from the body is classified as Class II.

(2) If the administration
or withdrawal by a device described in subrule (1) is potentially
hazardous, taking into account the nature of the administration or
withdrawal, the nature of the substance involved and the part of the body
concerned, the device is classified as Class III.

(3) A device described in
subrule (2) that is intended to control the treatment of a patient’s
condition through a closed loop system is classified as Class IV.

Rule 12:

Any other active device is
classified as Class I.

Special Rules

Rule
13:

A medical device that is
intended to be used for

(a) disinfecting or
sterilizing blood, tissues or organs that are intended for transfusion or
transplantation is classified as Class IV; and

(b) disinfecting or
sterilizing a medical device is classified as Class II.

Rule 14:

(1) Subject to subrule
(2), the following medical devices are classified as Class IV:

(a) a medical device that is manufactured from or
that incorporates human or animal cells or tissues or their derivatives;
and

(b) a medical device that is manufactured from or
that incorporates a product produced through the use of recombinant DNA
technology.

(2) A device described in
subrule (1) that is intended to come into contact with intact skin only is
classified as Class I.

Rule 15:

Any medical device that is a
material intended to be sold to a health care professional or dispenser
for the specific purpose of configuration or arrangement into a mould or
shape to meet the needs of an individual is classified in the class that
applies to the finished medical device.

Rule
16:

Despite rules 1 to 15, a
medical device set out in column 1 of an item of the table to this rule is
classified as the class set out in column 2 of that item.

TABLE

Column 1

Column 2

Item

Medical device

Class

1.

Breast implants

IV

2.

Tissue expanders for breast
reconstruction and augmentation

IV

PART 2
IN VITRO DIAGNOSTIC DEVICES

Use with respect to Transmissible Agents

Rule
1:

An IVDD that is intended to
be used to detect the presence of, or exposure to, a transmissible agent
in blood, blood components, blood derivatives, tissues or organs to assess
their suitability for transfusion or transplantation is classified as
Class IV.

Rule 2:

An IVDD that is intended to
be used to detect the presence of, or exposure to, a transmissible agent
is classified as Class II, unless

(a) it is intended
to be used to detect the presence of, or exposure to, a transmissible
agent that causes a life-threatening disease if there is a risk of
propagation in the Canadian population, in which case it is classified as
Class IV; or

(b) it falls into
one of the following categories, in which case it is classified as Class
III:

(i) it is intended to be used to detect the presence of,
or exposure to, a transmissible agent that causes a serious disease where
there is a risk of propagation in the Canadian population,

(ii) it is intended to be used to detect the presence of,
or exposure to, a sexually transmitted agent,

(iii) it is intended to be used to detect the presence of
an infectious agent in cerebrospinal fluid or blood, or

(iv) there is a risk that an erroneous result would cause
death or severe disability to the individual being tested, or to the
individual’s offspring.

Rule 3:

An IVDD that is intended to
be used for patient management is classified as Class II, unless it falls
into one of the following categories, in which case it is classified as
Class III:

(a) it is intended
to be used for the management of patients suffering from a
life-threatening disease; or

(b) there is a risk
that an erroneous result will lead to a patient management decision
resulting in an imminent life-threatening situation for the patient.

Other Uses

Rule 4:

An IVDD that is not subject
to rules 1 to 3 and that is intended to be used in diagnosis or patient
management is classified as Class II, unless it falls into one of the
following categories, in which case it is classified as Class III:

(a) it is intended
to be used in screening for or in the diagnosis of cancer;

(b) it is intended
to be used for genetic testing;

(c) it is intended
to be used in screening for congenital disorders in the fetus;

(d) there is a risk
that an erroneous diagnostic result would cause death or severe disability
to the patient being tested or to that patient’s offspring;

(e) it is intended
to be used for disease staging; or

(f) it is intended
to be used to monitor levels of drugs, substances or biological
components, if there is a risk that an erroneous result will lead to a
patient management decision resulting in an imminent life-threatening
situation for the patient.

Rule 5:

An IVDD that is intended to
be used for blood grouping or tissue typing to ensure the immunological
compatibility of blood, blood components, tissue or organs that are
intended for transfusion or transplantation is classified as Class III.

Special Rules

Rule 6:

A near patient IVDD is
classified as Class III.

Rule 7:

In cases where an IVDD,
including its analyzers, reagents and software, is intended to be used
with another IVDD, the class of both IVDDs will be that of the IVDD in the
class representing the higher risk.

Rule
8:

If rules 1 to 7 do not
apply, all other IVDDs are classified as Class I.

Rule
9:

Despite rules 1 to 8, an
IVDD set out in column 1 of an item of the table to this rule is
classified as the class set out in column 2 of that item.

TABLE

Column 1

Column 2

Item

IVDD

Class

1.

Near patient in
vitro diagnostic device for the detection of pregnancy or
for fertility testing

II

2.

Near patient in
vitro diagnostic device for determining cholesterol
level

II

3.

Microbiological media used to
identify or infer the identity of a microorganism

I

4.

IVDD used to identify or infer the
identity of a cultured microorganism

I

SOR/2007-119, s. 1.

SCHEDULE 2

(Section 1)

IMPLANTS

1. Heart valve

2. Annuloplasty ring

3. Active implantable device systems

(a) all models of implantable pacemakers and
leads;

(b) all models of implantable defibrillators and
leads;

(c) artificial heart;

(d) implantable ventricular support system; and

(e) implantable drug infusion system

4. Devices of human origin

(a) human dura mater; and

(b) wound covering containing human cells

SCHEDULE 3

(Section 89)

EXPORT CERTIFICATE FOR MEDICAL DEVICES

UNDER THE Medical Devices Regulations

I,   , certify that I
have knowledge of all matters contained in this certificate and that

1. I am (check applicable box)

(a) where the medical device described in this
certificate is exported by a corporation

☐ the exporter’s senior executive officer,

☐ the exporter’s senior regulatory officer,

☐ the authorized agent of the exporter’s senior executive officer, or

☐ the authorized agent of the exporter’s senior regulatory officer; and

(b) where the medical device described in this
certificate is exported by an individual

☐ the exporter, or

☐ the exporter’s authorized agent.

———————

, (State name
and address of exporter or, if a corporation, name and address of
principal place of business in Canada).

2. On the   day of   ,   , a package
containing   (description
of device, including serial number, model name, lot number and quantity,
as applicable; if additional space required, attach as Appendix “A”)
is/will be consigned to   (name and
address of consignee).

3. The package is marked in distinct overprinting with the word
“Export” or “Exportation”.

4. The medical device was not manufactured for consumption in Canada.

5. The medical device is not sold for consumption in Canada.

6. The package and its contents do not contravene any known requirement
of the law of the country of   (state country
of consignee).

7. All relevant information is contained in this certificate and no
relevant information has been knowingly withheld.

———————

Signature

———————

Position title

,

Date

AMENDMENT
NOT IN FORCE

-- SOR/2007-289, s. 3:

3. Subsection 24(1) of the Medical Devices
Regulations2 is replaced by the following:

2 SOR/98-282

24. (1) For the
purposes of subsections 3(1) and (2) of the Act and subject to section 27,
a condom may be advertised and sold to the general public for the purpose
of preventing the transmission of sexually transmitted diseases if the
advertisement and the label of the condom claim only that the condom
reduces the risk of transmitting sexually transmitted
diseases.

Last updated: 2008-03-17

Important
Notices

Last updated: 2008-03-17

Important
Notices

Last updated:
2008-03-17

Important
Notices