Regulation 12

For the purposes of section 17(1) of the Act and without prejudice to regulation 35A, a person who supplies a Class A medical device in accordance with regulation 10B must furnish such information about the medical device as the Authority may require.

The person mentioned in paragraph (1) must furnish the information within such time and in such manner as the Authority may specify.

For the purposes of paragraph (1), a medical device is 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.