Singapore legislation
Regulation 46
Regulation 46
Notification to Authority concerning field safety corrective action
Subregulation 1
Every manufacturer, importer, supplier or registrant of a medical device shall, before carrying out any field safety corrective action in relation to a medical device, notify the Authority of the intended field safety corrective action.
Subregulation 2
The notification referred to in paragraph (1) shall be made in such form and manner as the Authority may require.
Subregulation 3
Where the Authority has been notified of any intended field safety corrective action in relation to a medical device under paragraph (1), the Authority may, by notice in writing, require the manufacturer, importer, supplier or registrant of the medical device to do either or both of the following:
issue or cause to be issued, to such persons as the Authority may specify or to the general public, a statement informing them of the field safety corrective action;
take such other measures as the Authority thinks necessary.
Subregulation 4
Any person who contravenes paragraph (1) or fails to comply with a notice given to him by the Authority under paragraph (3) 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.
Subregulation 5
Any person who, in compliance or purported compliance with paragraph (1), furnishes the Authority with any notification 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.