Medical Devices Regulations (SOR/98-282)

Regulations are current to 2016-09-18 and last amended on 2016-07-17. Previous Versions

Issuance

 Subject to section 47, the Minister shall issue an establishment licence if the Minister determines that the application meets the requirements of section 45.

  • SOR/2011-82, s. 2.

Annual Review of Licence

  •  (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.

  • (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

  • SOR/2011-82, s. 2.

Refusal

  •  (1) The Minister may refuse to issue an establishment licence if the applicant has made a false or misleading statement in the application.

  • (2) The Minister shall refuse to issue an establishment licence if the Minister has reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons.

  • (3) If the Minister refuses to issue an establishment licence, the Minister shall

    • (a) notify the applicant in writing of the reasons for the refusal; and

    • (b) give the applicant an opportunity to be heard.

Notification

 If, following the issuance of an establishment licence, there is a change to any of the information submitted in accordance with 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.

Suspension

  •  (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.

  •  (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 injury 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.

 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.

  • SOR/2011-82, s. 3.

Cancellation

 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).

  • SOR/2011-82, s. 3.

Distribution Records

  •  (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.

 The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market.

  •  (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.

 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.

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

Complaint Handling

  •  (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.

 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.

Mandatory Problem Reporting

  •  (1) Subject to subsection (2), 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 inside or outside Canada and involving a device that is sold in Canada and that

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

    • (b) 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.

  • (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.

  •  (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.

 
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