Regulation 47

Every manufacturer, importer, supplier or registrant of a medical device who carries out any field safety corrective action in relation to the medical device must furnish to the Authority a report on the field safety corrective action no later than the 21st day after the date of the commencement of the field safety corrective action, or such longer period as the Authority may allow in the particular case.

The report referred to in paragraph (1) shall be made in such form and manner, and shall contain such information relating to the field safety corrective action, as the Authority may require.

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 report 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.