Medical Devices Regulations (SOR/98-282)

Annual Review

68.24 The holder of an authorization for a Class II, III or IV 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.

Notification — Suspension or Revocation

• 68.241 (1) This section applies to the holder of an authorization for a medical device that was issued in respect of an application submitted on the basis of subsection 68.11(4).

• (2) If the holder of an authorization for a medical device receives or becomes aware of information to the effect that the authorization or licence for sale of the device that was issued by the regulatory agency is suspended or revoked, the holder shall notify the Minister within 72 hours after they receive or become aware of the information, whichever occurs first.

• (3) However, the holder is not required to notify the Minister if they or the holder referred to in paragraph 68.3(1)(b) submits that information under section 68.3.

Discontinuance

68.25 If the holder of an authorization for a 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 medical device holds an authorization for the device, the importer of 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 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 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 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 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 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).

Serious Risk of Injury to Human Health

• 68.3 (1) This section applies to the following holders of therapeutic product authorizations:

  • (a) a holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device; and

  • (b) a holder of an establishment licence to import Class II, III or IV medical devices that imports a device referred to in paragraph (a).

• (2) The holder of a therapeutic product authorization 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 a device referred to in paragraph (1)(a), 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 that list; 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 that list.

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

• 68.301 (1) Despite subsection 68.3(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.

• (2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.

Summary Report

• 68.31 (1) The holder of an authorization for a Class II, III or IV 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 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 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 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 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 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 medical device for which the manufacturer 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 medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer 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

68.351 The Minister may add a medical condition to column 1 of the List of Medical Devices for Expanded Use 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.