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.