Regulation 43

Every licensee or registrant of a medical device shall, within 15 days after receiving any information which adversely affects the validity of any data furnished by him to the Authority relating to the quality, safety or efficacy of any medical device to which his licence or registration relates, inform the Authority of such information.

Any person who contravenes paragraph (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

Any person who, in compliance or purported compliance with paragraph (1), furnishes the Authority with any information which he knows is false or misleading 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.