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Medical Devices Regulations

Version of section 36 from 2006-03-22 to 2016-07-16:

  •  (1) If the Minister determines that a medical device in respect of which an application is submitted meets the safety and effectiveness requirements, the Minister shall

    • (a) issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or

    • (b) amend the medical device licence, in the case of an application for a medical device licence amendment.

  • (2) The Minister may set out in a medical device licence terms and conditions respecting

    • (a) the tests to be performed on a device to ensure that it continues to meet the safety and effectiveness requirements; and

    • (b) the requirement to submit the results and protocols of any tests performed.

  • (3) The Minister may amend the terms and conditions of the medical device licence to take into account any new development with respect to the device.

  • (4) The holder of the medical device licence shall comply with the terms and conditions of the licence.

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