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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2019-07-01 and last amended on 2019-06-17. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2019-191, s. 1

    • 1 The Medical Devices RegulationsFootnote 1 are amended by adding the following after section 61.1:

      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).

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