Singapore legislation
Regulation 13A
Regulation 13A
Supply of medical devices for use in clinical research
Subregulation 1
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.
Subregulation 2
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).
Subregulation 3
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.