Medical Devices Regulations

32.1 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.