Medical Devices Regulations
33 (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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