Complaints & Incident Reporting

The Medical Devices Regulations outline specific requirements for the handling and investigation of complaints, incident reporting (previously mandatory reporting) and foreign risk notification.  Requirements apply to both importers and medical device license holders.  Medical Device License holders are also responsible to prepare Summary Reports and Issue-Related Analyses, if requested by Health Canada.  DSA Consultants can prepare your safety reports and manage all of your Canadian reporting responsibilities.

If you sell Medical Devices and don’t have established procedures, then DSA Consultants can develop procedures  which meet Canadian regulatory requirements. DSA also provides external expertise for the investigation into complaints and incident reports, and any associated filings.