Singapore legislation
Regulation 44
Regulation 44
Notification to Authority concerning recall
Subregulation 1
For the purposes of section 44(1) of the Act, every manufacturer, importer, supplier or registrant of a medical device who intends to recall the medical device shall notify the Authority of the intended recall at least 24 hours before the time of the intended recall.
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 the intended recall of 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:
inspect the medical device and provide a report of the findings of the inspection; (b)take such other measures as the Authority thinks necessary.
Subregulation 4
Any person who 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.