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Medical Devices Regulations

Version of section 32.1 from 2006-03-22 to 2006-07-14:


 The Minister shall recognize a person as a registrar for the purpose of issuing quality system certificates if the person

  • (a) has sufficient training, experience and technical knowledge in the design and manufacture of medical devices and in the effective implementation of quality systems to determine whether a quality system satisfies a standard referred to in paragraph 32(2)(f), (3)(j) or (4)(p); and

  • (b) conducts quality system audits in accordance with the applicable guidelines and practices established by the International Organization for Standardization.

  • SOR/2003-173, s. 3
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