Medical Devices Regulations (SOR/98-282)

Notification

48 If, following the issuance of an establishment licence, there is a change to any of the information referred to in paragraph 45(a) or (b), the holder of the establishment licence shall submit the new information to the Minister within 15 days of the change.

Terms and Conditions

48.1 The Minister may, at any time, impose terms and conditions on an establishment licence, or amend those terms and conditions, after considering the following factors:

• (a) whether there are uncertainties relating to the manner in which an activity is or will be conducted;

• (b) whether the requirements under the Act are sufficient to protect patients, users or other persons from risks to health or safety;

• (c) whether compliance with the proposed terms and conditions is feasible; and

• (d) whether there are less burdensome ways to meet the objectives of the proposed terms and conditions.

Suspension

• 49 (1) Subject to subsection (3), the Minister may suspend an establishment licence if the Minister has reasonable grounds to believe that

  • (a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

  • (b) the licensee has made a false or misleading statement in the application; or

  • (c) failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.

• (2) Before suspending an establishment licence, the Minister shall consider

  • (a) the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

  • (b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

• (3) Subject to section 50, the Minister shall not suspend an establishment licence until

  • (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

  • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

  • (c) the licensee has been given an opportunity to be heard in respect of the suspension.

• 50 (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent risk to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

• (2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

• (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.

51 The Minister shall reinstate an establishment licence if the situation that gave rise to the suspension has been corrected or if the reason for the suspension was unfounded.

Cancellation

51.1 The Minister shall cancel an establishment licence in either of the following circumstances:

• (a) the licence has been suspended for a period of more than 12 months, or

• (b) the licence holder has failed to submit an application for the review of their licence in accordance with subsection 46.1(1).

Distribution Records

• 52 (1) The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device.

• (2) Subsection (1) does not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

53 The distribution record shall contain sufficient information to permit the complete and rapid recall of the medical device.

• 54 (1) The distribution record maintained by a manufacturer of an implant shall also contain a record of the information received on the implant registration cards forwarded to the manufacturer from a health care facility pursuant to section 67.

• (2) The manufacturer of an implant shall update the information referred to in subsection (1) in accordance with any information received from the health care facility or the patient.

55 The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of

• (a) the projected useful life of the device, and

• (b) two years after the date the device is shipped.

56 Distribution records shall be maintained in a manner that will allow their timely retrieval.

Complaint Handling

• 57 (1) The manufacturer, importer and distributor of a medical device shall each maintain records of the following:

  • (a) reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and

  • (b) all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph (a).

• (2) Subsection (1) does not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

58 The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out

• (a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and

• (b) an effective and timely recall of the device.

Incident Reporting

• 59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if

  • (a) the device is sold in Canada; and

  • (b) the incident

    • (i) is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and

    • (ii) 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 the incident to recur.

• (1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.

• (2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.

• 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.