Medical Devices Regulations (SOR/98-282)

• 41. (1) The Minister may suspend a medical device licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

• (2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

• (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.

42. The Minister may reinstate a medical device licence if the situation giving rise to the suspension has been corrected or if the reason for the suspension was unfounded.

• 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.

43.1 Subject to section 34, if a new or modified quality management system certificate is issued in respect of a licensed medical device, the manufacturer of the device shall submit a copy of the certificate to the Minister within 30 days after it is issued.

43.2 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.

43.3 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s medical device meets the requirements of the Act and these Regulations if

• (a) the manufacturer holds a medical device licence in respect of the device issued in accordance with section 36;

• (b) the Minister is satisfied that the manufacturer and the device comply with the Act and these Regulations;

• (c) the manufacturer has submitted to the Minister a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

• (d) the manufacturer has submitted to the Minister information regarding the manner in which the mark referred to in paragraph 43.5(1)(a) is applied to all permanent components of the device; and

• (e) the manufacturer has submitted to the Minister a sample of the label for the device that includes the information required by paragraph 43.5(1)(b).