13A. Supply of medical devices for use in clinical research

A person who manufactures a medical device under regulation 3A, imports a medical device under regulation 4C, or is supplied with a medical device under regulation 5B or 10A, may only supply the medical device —

as one whose planned use is a clinical purpose in any clinical research; or

as a medical device for some other purpose that the Authority has allowed and no other.

To avoid doubt, as from the time that the Authority has allowed the supply mentioned in paragraph (1)(b), the medical device ceases to be a medical device whose planned use is a clinical purpose in any clinical research for the purposes of these Regulations; but continues to be subject to any applicable law relating to medical devices (including these Regulations).

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.

A person who manufactures a medical device under regulation 3A, imports a medical device under regulation 4C, or is supplied with a medical device under regulation 5B or 10A, may only supply the medical device —

as one whose planned use is a clinical purpose in any clinical research; or

as a medical device for some other purpose that the Authority has allowed and no other.

To avoid doubt, as from the time that the Authority has allowed the supply mentioned in paragraph (1)(b), the medical device ceases to be a medical device whose planned use is a clinical purpose in any clinical research for the purposes of these Regulations; but continues to be subject to any applicable law relating to medical devices (including these Regulations).

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.