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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2020-03-05 and last amended on 2019-12-16. Previous Versions

PART 1General (continued)

Distribution Records (continued)

  •  (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.

  •  (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, 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.

  • SOR/2002-190, s. 5
  •  (1) Despite subsection 59(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 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.

  • SOR/2002-190, s. 5

Provision of Information Under Section 21.8 of Act

  •  (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).

  • SOR/2019-191, s. 1
 
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