Section 7

the medical device has been subjected to the conformity assessment procedures carried out by a conformity assessment body; and

the applicant has complied with any requirement of the Authority made under subsection 6(4), the Authority may, after such inspection of the premises in which the medical device is being manufactured as it considers proper and necessary to carry out and on payment of the prescribed registration fee, register the medical device for a prescribed period subject to such conditions as the Authority thinks fit to impose, assign a registration number to the medical device and issue to the applicant a certificate of registration.

The Authority shall not register the medical device if it is not satisfied with any matter referred to in subsection (1).

Medical Device 15

Power to impose additional conditions and to vary or revoke conditions