Medical Devices Regulations (SOR/98-282)

• 60 (1) A preliminary report shall be submitted to the Minister

  • (a) in respect of an incident that occurs in Canada

    • (i) within 10 days after the manufacturer or importer of a medical device becomes aware of an 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

    • (ii) within 30 days after the manufacturer or importer of a medical device becomes aware of an 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; and

  • (b) in respect of an incident that occurs outside Canada, as soon as possible after the manufacturer has indicated, to the regulatory agency referred to in paragraph 59(2), the manufacturer’s intention to take corrective action, or after the regulatory agency has required the manufacturer to take corrective action.

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

  • (a) the name of the 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) if the report is made by

    • (i) the manufacturer, the name and address of that manufacturer and of any known importer, and the name, title and telephone and facsimile numbers of a representative of the manufacturer to contact for any information concerning the incident, or

    • (ii) the importer of the device, the name and address of the importer and of the manufacturer, and the name, title and telephone and facsimile numbers of a representative of the importer to contact for any information concerning the incident;

  • (c) the date on which the incident came to the attention of the manufacturer or importer;

  • (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, address and telephone number, if known, of the person who reported the incident to the manufacturer or importer;

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

  • (g) the manufacturer’s or importer’s preliminary comments with respect to the incident;

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

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

• 61 (1) After the preliminary report is made in accordance with section 60, a final report shall be submitted to the Minister in accordance with the timetable established under paragraph 60(2)(h).

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

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

  • (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 as a result of the investigation referred to in paragraph 60(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.

• 61.1 (1) Despite subsection 59(1) or (1.1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer’s behalf if the information that the manufacturer and the importer must include is identical.

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

Serious Risk of Injury to Human Health

• 61.2 (1) This section applies to a holder of one of the following therapeutic product authorizations:

  • (a) a medical device licence; and

  • (b) an establishment licence to import Class II, III or IV medical devices.

• (2) The holder of a therapeutic product authorization issued in respect of a 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).

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

• 61.3 (1) Despite subsection 61.2(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

• 61.4 (1) The holder of a medical device licence shall prepare

  • (a) in the case of a Class II medical 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 medical 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 59(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 61.2(2).

• (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.

• 61.5 (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of 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.

• 61.6 (1) The holder of a medical device licence 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.

Provision of Information Under Section 21.8 of Act

• 62 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a medical device incident.

• (2) The following prescribed information about a medical device incident that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the medical device incident is first documented within the hospital:

  • (a) the name of the hospital and the contact information of a representative of that hospital;

  • (b) the name or identifier of the medical device;

  • (c) the date on which the medical device incident was first documented;

  • (d) the name of the manufacturer of the medical device;

  • (e) a description of the medical device incident;

  • (f) the lot number of the device or its serial number;

  • (g) any contributing factors to the medical device incident, including any medical condition of the patient that directly relates to the medical device incident; and

  • (h) the effect of the medical device incident on the patient’s health.

• (3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if

  • (a) the hospital does not have in its control all of the information referred to in paragraphs (2)(b) and (e) in respect of the medical device incident; or

  • (b) the medical device incident involves only a medical device that is the subject of an authorization issued under subsection 72(1) or 83(1).

• (4) The following definitions apply in this section.

  hospital

  hospital means a facility

  • (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or

  • (b) that is operated by the Government of Canada and that provides health services to in-patients. (hôpital)

  medical device incident

  medical device incident means an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were it to recur. (incident lié à un instrument médical)

• (5) For the purposes of the Act, medical device incident has the same meaning as in subsection (4).

Assessments Ordered Under Section 21.31 of the Act

• 62.1 (1) The Minister’s power to make an order under section 21.31 of the Act in respect of a medical device is subject to the following conditions:

  • (a) the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device; and

  • (b) the Minister shall have reasonable grounds to believe that the benefits — or the risks to the health or safety of patients, users or other persons — that are associated with the device are significantly different than they were when the medical device licence was issued or amended.

• (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a medical device,

  • (a) provide the holder of the medical device licence issued in respect of the device with the results of the examination; and

  • (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.

Activities Ordered Under Section 21.32 of the Act

62.2 The Minister’s power to make an order under section 21.32 of the Act in respect of a medical device is subject to the following conditions:

• (a) the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device;

• (b) the Minister shall have reasonable grounds to believe that

  • (i) there are significant uncertainties relating to the benefits or adverse effects associated with the device,

  • (ii) the licensee is unable to provide the Minister with information that is sufficient to manage those uncertainties, and

  • (iii) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the medical device licence, do not allow for sufficient information to be obtained to manage those uncertainties; and

• (c) the Minister shall take into account the following matters:

  • (i) whether the activities that the licensee will be ordered to undertake are feasible, and

  • (ii) whether there are less burdensome ways of obtaining additional information about the device’s effects on the health or safety of patients, users or other persons.