Medical Devices Regulations (SOR/98-282)

68.14 An application to amend an authorization shall be submitted to the Minister by the holder of the authorization in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to amend the authorization, including the information and documents referred to in subsection 68.11(2) and (3) that relate to the change referred to in section 68.13 for which an amendment to the authorization is required.

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

• (a) the holder of the authorization has submitted an application to the Minister that meets the requirements set out in section 68.14;

• (b) 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 or the absence of any such need; and

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

Refusal

68.16 The Minister may refuse to issue or amend an authorization for a COVID-19 medical device if

• (a) the Minister has reasonable grounds to believe that the manufacturer of the device has contravened these Regulations or any provision of the Act relating to medical devices;

• (b) the Minister has reasonable grounds to believe that the device is not labelled in accordance with sections 21 and 23; or

• (c) the manufacturer of the device has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to issue or amend the authorization, within the time limit specified in the request.

68.17 The Minister shall refuse to amend an authorization for a COVID-19 medical device in the case where the application to amend the authorization indicates that the holder of the authorization intends, if the authorization were to be amended, that the device would not be manufactured, sold or represented for use in relation to COVID-19.

68.18 If the Minister refuses to issue or amend an authorization, the Minister shall notify the manufacturer of the COVID-19 medical device in writing of the reasons for the refusal and give them an opportunity to be heard.

Terms and Conditions

68.19 The Minister may, at any time, impose terms and conditions on an authorization for a COVID-19 medical device or amend those terms and conditions.

Applications Submitted Under Part 1

68.2 Despite section 68.03, the holder of an authorization for a COVID-19 medical device may submit

• (a) in the case of a Class I device, an application under section 45 for an establishment licence that would authorize the holder to sell or import the device; or

• (b) in the case of a Class II, III or IV device, an application under section 32 for a licence for the device.

Cancellation

• 68.21 (1) The Minister may cancel an authorization for a COVID-19 medical device by written notice to the holder, giving reasons, if

  • (a) the Minister has reasonable grounds to believe that the holder has contravened these Regulations or any provision of the Act relating to medical devices;

  • (b) the Minister has reasonable grounds to believe that the risks associated with the device outweigh the benefits 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 or the absence of any such need;

  • (c) the Minister has reasonable grounds to believe that the holder does not have 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;

  • (d) the Minister has reasonable grounds to believe that the health or safety of patients, users or other persons may be unduly affected by the device;

  • (e) the Minister has reasonable grounds to believe that the holder has failed to comply with the terms and conditions of the authorization;

  • (f) in the case of an authorization issued in respect of an application submitted on the basis of subsection 68.11(4), the Minister becomes aware that the authorization or licence for sale of the device that had been issued by the regulatory agency is suspended or revoked;

  • (g) the holder has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to cancel the authorization, within the time limit specified in the request;

  • (h) in the case of a Class I device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, submit an application under section 45 for an establishment licence that would authorize the holder to sell or import the device,

    • (ii) the Minister refuses to issue an establishment licence to the holder under section 47, or

    • (iii) the holder withdraws the application referred to in subparagraph (i);

  • (i) in the case of a Class II device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

      • (A) the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(2)(f), and

      • (B) the contract is in effect when that period expires, or

    • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f); or

  • (j) in the case of a Class III or IV device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

      • (A) the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(3)(j) or (4)(p), as the case may be, and

      • (B) the contract is in effect when that period expires, or

    • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(3)(j) or (4)(p), as the case may be.

• (2) A ground for cancellation specified in subparagraph (1)(i)(i) or (j)(i) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be, or a copy of the contract referred to in the applicable subparagraph.

• (3) A ground for cancellation specified in subparagraph (1)(i)(ii) or (j)(ii) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be.

68.22 An authorization for a COVID-19 medical device is cancelled if

• (a) in the case of a Class I device, the holder of the authorization is issued an establishment licence under section 46 that authorizes the holder to sell or import the device;

• (b) in the case of a Class II, III or IV device, the holder of the authorization is issued a licence for the device under section 36; or

• (c) the holder of the authorization informs the Minister under section 68.25 that the sale of the device has been discontinued in Canada.

Additional Information and Material

68.23 The Minister may request that the manufacturer of a COVID-19 medical device who has submitted an application for an authorization or the holder of an authorization submit to the Minister, within a specified time limit, any additional information or documents or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.

Annual Review

68.24 The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall, annually before November 1 and in a form established by the Minister, provide the Minister with a statement signed by the holder or a person authorized to sign on the holder’s behalf

• (a) confirming that all the information and documents submitted by the holder with respect to the device are still correct; or

• (b) describing any change to the information and documents submitted by the holder with respect to the device, other than those to be submitted under section 68.14 or 68.34.

Discontinuance

68.25 If the holder of an authorization for a COVID-19 medical device discontinues the sale of the device in Canada, the holder shall inform the Minister within 30 days after the discontinuance.

Importation — Copy of Authorization

68.26 If the manufacturer of a COVID-19 medical device holds an authorization for the device, a person who imports a shipment of the device shall ensure that the shipment is accompanied by a copy of the authorization.

Incident Reporting

• 68.27 (1) The holder of an authorization for a COVID-19 medical device shall submit a preliminary report to the Minister in respect of any incident that comes to their attention occurring in Canada that involves the device

  • (a) within 10 days after becoming aware of the 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

  • (b) within 30 days after becoming aware of the 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.

• (2) The preliminary report shall contain the following information:

  • (a) the name of the COVID-19 medical 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 names and addresses of the holder and of any known importer of the COVID-19 medical device as well as the name, title and contact information of a representative of the holder to contact for any information concerning the incident;

  • (c) the date on which the holder became aware of the incident;

  • (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 and contact information, if known, of the person who reported the incident to the holder;

  • (f) the names of any other medical devices involved in the incident, including any accessories, if known;

  • (g) the preliminary comments of the holder with respect to the incident;

  • (h) the course of action, including an investigation, that the holder proposes to follow in respect of the incident and a timetable for carrying out any proposed action and submitting a final report; and

  • (i) a statement indicating whether a previous report has been made to the Minister with respect to the COVID-19 medical device and, if so, the date of the report.

• 68.28 (1) The holder of the authorization shall, after making the preliminary report, submit a final report to the Minister in accordance with the timetable established under paragraph 68.27(2)(h).

• (2) The final report shall contain the following information:

  • (a) a description of the incident, including the number of persons who have died or experienced a serious deterioration in the state of their health;

  • (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 in respect of the COVID-19 medical device as a result of the investigation referred to in paragraph 68.27(2)(h), 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.

68.29 The holder of the authorization is not required to submit the preliminary report referred to in section 68.27 or the final report referred to in section 68.28 if

• (a) the information that the holder would be required to include in that preliminary report is identical to the information that the importer of the device is required to include in the preliminary report referred to in subsection 59(1);

• (b) the information that the holder would be required to include in that final report is identical to the information that the importer of the device is required to include in the final report referred to in subsection 59(1); and

• (c) the holder advises the Minister in writing that the importer of the device is submitting the preliminary report and the final report under subsection 59(1).