Medical Device Complaints & Mandatory Problem Reporting

DSA Consultants offers a full range of services to assist clients with compliance to the Canadian Medical Device Regulations under the Food & Drugs Act (FDA).

Some clients use our servies to:

• Assess the adequacy of investigations into product complaints
• Determine if complaints should result in filing of mandatory problem reports
• Manage the full investigation into product complaints
• Determination of reporting requirements
• Handling of the reporting process with Health Canada

Complaints

The Canadian Medical Device Regulations require that you have established procedures in place for complaints handling and investigation. If you sell medical devices, and you currently don’t have established procedures for these activities, then DSA can develop programs for you, which meet regulatory requirements.

If you don’t have resources on staff to assist you with investigations into quality complaints, then a DSA Quality Consultant can provide you with this expertise. We can review complaints, spearhead the investigation into the complaints, either directly or by dealing with your fabricators, and then ensure that the complaint can be closed out and resolved. We can also supplement your in-house quality teams to ensure that complaints have been satisfactorily addressed.

Mandatory Problem Reporting

The Medical Device Regulations outline specific requirements for mandatory problem reporting to Health Canada and require that you have written procedures to address these requirements.

DSA can help you develop protocols which delineate your responsibilities for reporting, if and when, device related failures occur.

A DSA consultant can help you determine if your complaints meet the requirements for mandatory problem reporting. If your device related failure does meet the requirements for mandatory problem reporting, DSA can prepare the filings on your behalf. We can also assist you with the investigation and advise you on whether or not your investigations are sufficient.

Contact us, to find out more information on Complaints and Mandatory Problem Reporting and how DSA can be of assistance to you. Or click here, to receive a copy of our white paper on marketing a therapeutic product in Canada.