Interpretation

1 The definitions in this section apply in these Regulations.

Act

Act means the Food and Drugs Act. (Loi)

active device

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

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

active therapeutic device means an active device that, whether used alone or in combination with another 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

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

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

central cardiovascular system

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

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

closed-loop system

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

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

control number

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

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

dental material[Repealed, SOR/2002-190, s. 1]

directions for use

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

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

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

genetic testing

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

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

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

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

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

invasive device

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

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 vitroouIDIV)

manufacturer

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

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

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

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

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

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

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

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

person includes a partnership and an association. (personne)

qualified investigator

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

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

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

recall

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

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

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

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

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

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

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

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

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)

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 1General

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.

• 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.

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 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.

• (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.

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.

Quality Management System Certificate

32.1 The Minister shall recognize a person as a registrar for the purpose of issuing, renewing, suspending or cancelling 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 and issues, renews, suspends and cancels quality management system certificates in accordance with the applicable guidelines and practices established by the International Organization for Standardization.

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

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

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.

• 32.5 (1) Subject to subsection (2), the Minister may cease to recognize a person as a registrar if the Minister has reasonable grounds to believe that the person no longer meets the requirements of section 32.1 or fails to comply with section 32.3 or 32.4.

• (2) Subject to section 32.6, the Minister shall not cease to recognize a person as a registrar unless

  • (a) the Minister has sent the registrar a written notice that sets out the reason for the proposed cessation of recognition, 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 registrar has been given an opportunity to be heard in respect of the proposed cessation of recognition.

• 32.6 (1) The Minister may cease to recognize a person as a registrar without giving the registrar 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 registrar a notice in writing that states the reason for the cessation of recognition.

• (2) A registrar may ask the Minister, in writing, that the cessation of recognition be reconsidered.

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

32.7 The Minister may reinstate the recognition of a person as a registrar if the situation giving rise to the cessation of recognition has been corrected or if the cessation of recognition was unfounded.

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.

• 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.

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.

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

Application

43.2 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, 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.

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).

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.

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.

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.

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 A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents:

• (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 Subject to section 47, the Minister shall issue an establishment licence if the Minister determines that the application meets the requirements of section 45.

Annual Review of Licence

• 46.1 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.

• (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

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 shall reinstate an establishment licence if the situation that gave rise to the suspension has been corrected or if the reason for the suspension was unfounded.

Cancellation

51.1 The Minister shall cancel an establishment licence in either of the following circumstances:

• (a) the licence has been suspended for a period of more than 12 months, or

• (b) the licence holder has failed to submit an application for the review of their licence in accordance with subsection 46.1(1).

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.

• 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.

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.

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 2Custom-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.

PART 3Medical 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.

• 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.

PART 4Export 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 5Transitional 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 [Repeal]

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.