Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purpose of applying conformity assessment procedures to a kind of medical device, a power or function of the Secretary, in relation to an assessment to be conducted under the procedures, may be exercised or performed at the place where the manufacturer is located, and at the manufacturing site, by a body or authority that the Secretary is satisfied has the authority and expertise to exercise that power or perform that function.
(2) If, under the conformity assessment procedures, the
manufacturer of the kind of medical device is required to give information of
a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the
Secretary, the information must be given to the Secretary in addition to any
such information that is given to the body or authority mentioned in
subregulation (1).