Medical Devices Regulations
32.1 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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