10B. Exception for Class A medical devices

Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of a Class A medical device that is —

manufactured under a valid manufacturer’s licence or in accordance with regulation 3C;

imported by the supplier under a valid importer’s licence; or

obtained by the supplier from a wholesaler who holds a valid wholesaler’s licence.

For the purposes of paragraph (1), a medical device shall be treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered.

Despite any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product does not apply to the supply of a Class A medical device that is —

manufactured under a valid manufacturer’s licence or in accordance with regulation 3C;

imported by the supplier under a valid importer’s licence; or

obtained by the supplier from a wholesaler who holds a valid wholesaler’s licence.

For the purposes of paragraph (1), a medical device shall be treated as a Class A medical device if it would have been assigned to Class A according to regulation 24 had the medical device been registered.