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Medical Devices Regulations

Version of section 32.1 from 2006-07-15 to 2009-11-18:


 The Minister shall recognize a person as a registrar for the purpose of issuing quality management 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 management systems to determine whether a quality management system satisfies a standard referred to in paragraph 32(2)(f), 3(j) or 4(p); and

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

  • SOR/2003-173, s. 3
  • SOR/2006-197, s. 3
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