Medical Devices Regulations (SOR/98-282)

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, as defined in subsection 1(2) of the Cannabis Regulations, containing cannabis, as defined in subsection 2(1) of the Cannabis Act, or 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.

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 applicable requirements of sections 10 to 20.

• (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 (1) A medical device other than a decorative contact lens 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.

• (2) A decorative contact lens shall not adversely affect the health or safety of a user, except to the extent that a possible adverse effect of the device constitutes a risk that is compatible with a high level of protection of health and safety.

• 12 (1) A medical device other than a decorative contact lens 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.

• (2) A decorative contact lens shall perform as intended by the manufacturer.

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, as well as the performance specifications of the device if those specifications are necessary for proper use;

  • (i) the directions for use, unless directions are not required

    • (i) in the case of a decorative contact lens, for the device to be used safely, and

    • (ii) in the case of any other medical device, 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.

21.1 Despite section 21, any person who imports for sale a medical device that is not labelled in accordance with these Regulations shall ensure

• (a) if that person holds an establishment licence to import the medical device, that they send prior notice of the proposed importation to the Minister or, if they do not hold such a licence, that the manufacturer of the medical device sends the prior notice; and

• (b) before selling the medical device, that the manufacturer of the medical device has relabelled it in accordance with these Regulations within three months after the date of its importation.

21.2 Any person who imports for sale a medical device that is not labelled in accordance with these Regulations shall ensure that the manufacturer of the medical device notifies the Minister in writing of the name of the person who will relabel it in Canada if it is to be relabelled on the manufacturer’s behalf.

• 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 his or her attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, an analysis or other 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 the medical device if

  • (a) the manufacturer has not complied with the request on or before the day specified in the request; or

  • (b) the Minister determines, on the basis of the information submitted, that the device does not meet the applicable requirements of sections 10 to 20.

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

  • (a) the Minister determines, on the basis of the information submitted, that the medical device meets the applicable requirements of sections 10 to 20;

  • (b) corrective action has been taken to ensure that the medical device meets the applicable requirements of sections 10 to 20; 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;

• (a.1) the manufacturer of the device holds an authorization issued under section 68.12 in respect of that device or, if the device has been subjected to a change described in section 68.13, an amended authorization; 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 applicable requirements of sections 10 to 20;

  • (c) an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the applicable requirements of sections 10 to 20;

  • (d) a copy of the device label;

  • (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 meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

• (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 applicable requirements of sections 10 to 20;

  • (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 applicable requirements of sections 10 to 20, 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 meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.

• (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 applicable requirements of sections 10 to 20;

  • (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 applicable requirements of sections 10 to 20;

  • (i) detailed information on all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, 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 meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.