Medical Devices Regulations

68.34 (1) If a new or modified quality management system certificate is issued in respect of a COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.

(2) Subsection (1) does not apply if the manufacturer includes the new or modified quality management system certificate in an application to amend the authorization that is submitted under section 68.14.