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Section 12

Registration and refusal to register conformity assessment body

of Medical Device Act 2012

ActIn forceProvision 12 of 80
Section 12
(1)

Upon receipt of an application made under subsection 11(2) and the

Authority being satisfied of the compliance with any requirement under subsections 11(4) and (5), the Authority may, after such inspection of the premises of the conformity assessment body as it considers proper and necessary to carry out and on payment of the prescribed registration fee, register the conformity assessment body for a prescribed period subject to such conditions as the Authority thinks fit to impose, assign a registration number to the conformity assessment body and issue to the conformity assessment body a certificate of registration.

(2)

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