Medical Devices Regulations (SOR/98-282)

Record Keeping

65.3 A manufacturer or importer of a medical device who recalls the device without being ordered to do so by the Minister shall keep a record of the following:

• (a) a document that sets out the decision to conduct the recall, including

  • (i) the name and title of the individual who made the decision, and

  • (ii) the date the decision was made;

• (b) the date the recall was completed;

• (c) the information and documents referred to in sections 63.2, 64 and 65; and

• (d) the document provided to the Minister under subsection 65.1(2), if applicable.

• 65.4 (1) Subject to subsection (2), a distributor of a medical device who conducts a recall of the device that was not ordered by the Minister shall keep a record of the following:

  • (a) the name of the device;

  • (b) 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;

  • (c) in the case of a licensed device, the medical device licence number;

  • (d) in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;

  • (e) the name and address of

    • (i) the manufacturer,

    • (ii) the establishment where the device was manufactured, if different from that of the manufacturer,

    • (iii) the importer, and

    • (iv) the person who sold them the device;

  • (f) the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and circumstances under which the defectiveness or potential defectiveness was discovered;

  • (g) the number of affected units of the device that the distributor sold in Canada;

  • (h) the period during which the affected units of the device were distributed in Canada by the distributor;

  • (i) the name of each person to whom the affected device was sold by the distributor and the number of units of the device sold to each person;

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

  • (k) the results of the recall; and

  • (l) the date the recall was completed.

• (2) A distributor who initiates the recall shall keep a record of the following:

  • (a) the information and documents referred to in subsection (1);

  • (b) an evaluation of the risk associated with the defectiveness or potential defectiveness of the medical device to which the recall relates; and

  • (c) the actions that were proposed and actions taken to prevent a recurrence of the problem.

65.5 A person who is ordered by the Minister to recall a medical device shall keep a record of the information and documents provided to the Minister under section 65.2.

• 65.6 (1) A manufacturer who is required to keep a record under section 65.3 or 65.5 shall keep it for at least the longer of the following periods:

  • (a) the period that is equivalent to the projected useful life of the medical device to which the recall relates plus two years; and

  • (b) the period during which the device is sold in Canada.

• (2) Any other person who is required to keep a record under section 65.3, 65.4 or 65.5 shall keep it for at least a period equivalent to the projected useful life of the device to which the recall relates plus two years.

• (3) For the purpose of paragraph (1)(a) and subsection (2), the retention period begins on the day on which the recall is completed.

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 an Urgent Public Health Need

Definitions and Interpretation

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[Repealed, SOR/2023-277, s. 3]

COVID-19 medical device

COVID-19 medical device[Repealed, SOR/2023-277, s. 3]

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 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 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:

• (a) a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;

• (b) a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)

68.011 For the purposes of paragraphs 68.21(1)(h), (i) and (j), and sections 68.24, 68.3, 68.31 and 68.34, a medical device for which the manufacturer holds an authorization is considered not to be a UPHN medical device if

• (a) the device is not set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and does not belong to a category of medical devices that is set out in column 2 of Part 2 of that list; or

• (b) the device is set out in column 2 of Part 1 of that list or belongs to a category of medical devices that is set out in column 2 of Part 2 of that list but is not authorized in relation to a corresponding medical condition that is set out, as the case may be, in column 1 of Part 1 or column 1 of Part 2.

Application

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

• (2) [Repealed, SOR/2023-277, s. 5]

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 medical device if the manufacturer holds an authorization for the device.

• (2) However, the following provisions of Part 1 apply in respect of the importation or sale of the 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, 27, 52 to 58, 62 and 62.21 to 65.6.

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

Advertising — Authorized Class I Medical Device

68.031 No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless

• (a) the manufacturer holds 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 authorized in accordance with Canadian law.

Deemed Authorization

68.04 [Repealed, SOR/2023-277, s. 8]

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 condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that

  • (a) the medical condition presents, or is the result of, a significant risk to public health in Canada; and

  • (b) immediate action is required to deal with the risk.

• (2) The Minister may add a medical device to column 2 of 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 for the device that is related to the corresponding medical condition that is set out in column 1.

• (3) The Minister may add a category of medical devices to column 2 of 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 for the devices that belong to that category that is related to the corresponding medical condition set out in column 1.