Medical Devices Regulations (SOR/98-282)

Serious Risk of Injury to Human Health

• 68.3 (1) The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding

  • (a) risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;

  • (b) changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in the list referred to in paragraph (a); and

  • (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in the list referred to in paragraph (a).

• (2) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

• (3) The holder is not required to provide the information if

  • (a) the importer of the COVID-19 medical device is required to provide identical information under subsection 61.2(2); and

  • (b) the holder advises the Minister in writing that the importer is submitting the information under that subsection.

Summary Report

• 68.31 (1) The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall prepare

  • (a) in the case of a Class II device, on a biennial basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 24 months; and

  • (b) in the case of a Class III or IV device, on an annual basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 12 months.

• (2) The information to be covered by the summary report is that in respect of

  • (a) adverse effects;

  • (b) problems referred to in paragraph 57(1)(a);

  • (c) incidents referred to in subsection 68.27(1); and

  • (d) serious risks of injury to human health that are relevant to the safety of the COVID-19 medical device and are referred to in subsection 68.3(1).

• (3) The summary report shall contain a concise critical analysis of the information referred to in subsection (2).

• (4) In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the COVID-19 medical device has changed in any of the following ways:

  • (a) the potential benefits for patients through the use of the device may be less;

  • (b) in respect of each of the risks,

    • (i) the harm associated with the risk is more likely to occur, or

    • (ii) if the harm associated with the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and

  • (c) a new risk has been identified.

• (5) The holder shall include the conclusions they reach under subsection (4) in the summary report.

• (6) If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the COVID-19 medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.

• 68.32 (1) The Minister may, for the purposes of determining whether there is sufficient evidence to support the conclusion that the benefits associated with a COVID-19 medical device outweigh the risks, request that the holder of an authorization for the device submit, within a specified time limit, any of the following:

  • (a) summary reports; or

  • (b) information on the basis of which summary reports were prepared.

• (2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.

• 68.33 (1) The holder of an authorization for a COVID-19 medical device shall maintain records of the summary reports and the information on the basis of which those reports were prepared.

• (2) The holder shall retain the records for seven years after the day on which they were created.

Obligation to Submit Certificate

• 68.34 (1) If a new or modified quality management system certificate is issued in respect of a COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.

• (2) Subsection (1) does not apply if the manufacturer includes the new or modified quality management system certificate in an application to amend the authorization that is submitted under section 68.14.

Sale — Cancellation of Authorization

68.35 Subject to sections 21, 23 and 44, if an authorization for a COVID-19 medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer of the device may sell the device, despite any other provision in Part 1, for a period of six months beginning on the day on which the authorization is cancelled.

Expanded Use

• 68.36 (1) The Minister may add a licensed medical device or a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization to column 1 of the List of Medical Devices for Expanded Use and an expanded use to column 2 only if the following conditions are met:

  • (a) the Minister has reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the expanded use of the device;

  • (b) the Minister has sufficient evidence to support the conclusion that the benefits associated with the expanded use 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; and

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

• (2) In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

  • (a) the device is set out in column 1 of the List of Medical Devices for Expanded Use; and

  • (b) the expanded use of the device is set out in column 2 of the list referred to in paragraph (a).

• (3) In the case of a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

  • (a) the device is set out in column 1 of the List of Medical Devices for Expanded Use; and

  • (b) the expanded use of the device is set out in column 2 of the list referred to in paragraph (a).

68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 2 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization — set out in column 1 of that List, including

• (a) a statement of the expanded use;

• (b) a statement of the known and potential benefits and risks; and

• (c) any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively.

• 68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device set out in column 1 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use set out in column 2 of that List that the holder possesses or to which they have reasonable access.

• (2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV COVID-19 medical device set out in column 1 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 2 of that List that the holder possesses or to which they have reasonable access.

• (3) The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request.

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) a licensed medical device that is available for sale in Canada, or

      • (B) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and 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;

  • (c.1) a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that would adequately meet the requirements of the patient is not available for sale in Canada; and

  • (d) the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1 or 1.1.

• (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.