Post-Market Surveillance, Complaints & Mandatory Problem Reporting
Canadian market access continues after licensing. Manufacturers, importers and distributors must maintain complaint, reporting, recall and corrective-action systems capable of identifying and responding to device risks.
Our Post-Market Support Includes
Reporting Timelines:
For incidents occurring in Canada, a preliminary report is generally due within 10 calendar days when death or serious deterioration in health has occurred, and within 30 calendar days when such an outcome did not occur but could occur if the incident recurred.
Expert Focus:
We do not treat complaints as isolated quality records. We connect complaint data to reportability, risk, CAPA, recall decisions, licence impact and the technical evidence supporting the device.
Maintain Rigorous Health Canada Vigilance and Post-Market Compliance
Our post-market specialists assess incident reportability, lodge MPR notifications, and manage recall communications.