Medical Devices Regulations (SOR/98-282)

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 1.1Medical Devices for Use in Relation to COVID-19

Definitions

68.01 The following definitions apply in this Part.

authorization

authorization means, unless the context requires otherwise, an authorization that is issued under section 68.12. (autorisation)

COVID-19

COVID-19 means the coronavirus disease 2019. (COVID-19)

COVID-19 medical device

COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical contre la COVID-19)

List of Medical Devices for an Urgent Public Health Need

List of Medical Devices for an Urgent Public Health Need means the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)

List of Medical Devices for Expanded Use

List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)

UPHN medical device

UPHN medical device means any of the following medical devices for an urgent public health need related to COVID-19:

• (a) a medical device that is set out in Part 1 of the List of Medical Devices for an Urgent Public Health Need;

• (b) a medical device that belongs to a category of medical devices that is set out in Part 2 of the List of Medical Devices for an Urgent Public Health Need. (instrument médical BUSP)

Application

• 68.02 (1) This Part applies to medical devices that are not subject to Part 2 or 3.

• (2) However, this Part does not apply to Class I medical devices that are not COVID-19 medical devices.

Authorization

Non-application of Part 1 — Importation and Sale

• 68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a COVID-19 medical device if the manufacturer of the device holds an authorization for the device.

• (2) However, the following provisions of Part 1 apply in respect of the importation or sale of the COVID-19 medical device:

  • (a) in the case of an importer, sections 59 to 61;

  • (b) in the case of an importer or distributor, sections 44 to 51.1; and

  • (c) sections 21, 23 and 27, 52 to 58, 62 and 62.21 to 65.1.

• (3) Despite paragraph (2)(b), subsection 44(3) does not apply if the COVID-19 medical device that is imported is a Class I device and the person from whom the device is imported is the manufacturer.

Deemed Authorization

68.04 Sections 68.05 to 68.09 apply to COVID-19 medical devices.

68.05 In sections 68.06 to 68.09, authorized, in relation to a medical device, means that the device is the subject of an authorization.

68.06 If a system is authorized, 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 be authorized.

68.07 If a test kit is authorized, 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 be authorized.

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

• 68.09 (1) If all the medical devices that form part of a medical device group are authorized, that medical device group is deemed to be authorized.

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

Application for an Authorization

• 68.1 (1) The Minister may add a medical device to Part 1 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the device.

• (2) The Minister may add a category of medical devices to Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the devices that belong to that category.

• 68.11 (1) A manufacturer of a COVID-19 medical device may submit to the Minister an application for an authorization for the device if it is a UPHN medical device.

• (2) The application shall be submitted in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to issue the authorization, including

  • (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;

  • (e) the name and address of the establishment where the device is manufactured, if different from those referred to in paragraph (d);

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

  • (g) information respecting the safety and effectiveness of the device;

  • (h) evidence that establishes that the manufacturer has a quality management system in place in respect of the device;

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

  • (j) an attestation by the manufacturer that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls; and

  • (k) a copy of the device label.

• (3) An application in respect of a Class III or IV COVID-19 medical device shall contain, in addition to the information and documents referred to in subsection (2),

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

  • (b) 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.

• (4) Despite subsection (2) and subsection (3), the application need not include the information and documents referred to in paragraphs (2)(g) and (h) and, if applicable, subsection (3) if

  • (a) the application includes information that demonstrates that an authorization or licence for sale of the COVID-19 medical device has been issued by a regulatory agency and that the authorization or licence has not been suspended or revoked; and

  • (b) the name of the regulatory agency appears in the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.

Issuance

68.12 The Minister shall issue an authorization for a COVID-19 medical device if the following requirements are met:

• (a) the manufacturer of the device has submitted an application to the Minister that meets the requirements set out in section 68.11;

• (b) the device is a UPHN medical device;

• (c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to

  • (i) the uncertainties relating to those benefits and risks, and

  • (ii) the urgent public health need for the device;

• (d) the Minister has sufficient evidence to support the conclusion that the manufacturer has a quality management system in place that is adequate to

  • (i) control the quality and, if applicable, the purity and sterility of the device and the materials used in the manufacture of the device, and

  • (ii) ensure that the device meets the specifications of the device; and

• (e) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.

Amendment

68.13 No person shall import or sell a COVID-19 medical device for which the manufacturer holds an authorization if the device has been the subject of any of the following changes unless the manufacturer holds an amended authorization:

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

• (b) a change that would result in a change of 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 device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.