Medical Devices Regulations

43 (1) Every manufacturer of a licensed medical device shall, annually before November 1 and in a form authorized by the Minister, furnish the Minister with a statement signed by the manufacturer or by a person authorized to sign on the manufacturer’s behalf

• (a) confirming that all the information and documents supplied by the manufacturer with respect to the device are still correct; or

• (b) describing any change to the information and documents supplied by the manufacturer with respect to the device, other than those to be submitted under section 34 or 43.1.

(2) If the manufacturer fails to comply with subsection (1), the Minister may cancel the medical device licence.

(3) If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuance, and the licence shall be cancelled at the time that the Minister is informed.