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Medical Devices Regulations

Version of section 33 from 2016-07-17 to 2020-06-17:

  •  (1) If an application for a medical device licence is submitted by a manufacturer of a country other than Canada, the information and documents described in subsections 32(2) to (4) need not be submitted if

    • (a) the applicant is governed, in that country, by a regulatory authority that is recognized by the Minister; and

    • (b) the application is accompanied by a certificate of compliance and a supporting summary report, issued by a conformity assessment body of that country that is recognized by the Minister, which certify that the medical device meets the applicable requirements of sections 10 to 20.

  • (2) For the purposes of subsection (1), the Minister may recognize a regulatory authority and a conformity assessment body of a country other than Canada only if it has the ability to determine whether the device meets the applicable requirements of sections 10 to 20.

  • (3) The Minister shall, on request, make available to any interested persons the list of recognized regulatory authorities and conformity assessment bodies of countries other than Canada.

  • SOR/2015-193, s. 7
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