Medical Devices Regulations

61.2 (1) This section applies to a holder of one of the following therapeutic product authorizations:

• (a) a medical device licence; and

• (b) an establishment licence to import Class II, III or IV medical devices.

(2) The holder of a therapeutic product authorization issued in respect of a medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding

• (a) risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;

• (b) changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in the list referred to in paragraph (a); and

• (c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in the list referred to in paragraph (a).

(3) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.