Medical Devices Regulations

68.3 (1) The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN 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).

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

(3) The holder is not required to provide the information if

• (a) the importer of the COVID-19 medical device is required to provide identical information under subsection 61.2(2); and

• (b) the holder advises the Minister in writing that the importer is submitting the information under that subsection.