Regulation 32

A manufacturer, importer, supplier or registrant of any medical device shall comply with such conditions, for the grant to the manufacturer, importer, supplier or registrant of any licence in respect of that medical device, or for the registration of that medical device, as the Authority may impose.

Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

Without prejudice to paragraph (2), the Authority may suspend or cancel the licence or registration, as the case may be, which the Authority has granted to a person, if that person contravenes paragraph (1).