CANADA - Ongoing Compliance Key Requirements

CANADA Ongoing Compliance Key Requirements 

Distribution Records

Under Canadian Medical Device Regulations, manufacturers, importers, and distributors must maintain comprehensive distribution records for each device.

• A documented procedure must be included in the Quality Management System (QMS).
• Records must contain sufficient detail to enable a complete and rapid withdrawal of the device from the market if necessary.
• The Regulations specify minimum retention periods and require records to be maintained in a manner that ensures timely retrieval.

Complaint Handling

Manufacturers, importers, and distributors are required to maintain records of all reported problems related to medical devices they have sold.

• Complaint handling procedures must be documented in the QMS.
• Records should capture the nature of the complaint, investigation results, and corrective actions taken.

Mandatory Problem Reporting

Canadian Regulations require importers and manufacturers to report specific incidents involving medical devices on the market.

• A documented procedure must be included in the QMS.
• Reporting obligations cover:
  • Serious risks of injury to human health
  • Recalls
  • Shortages and discontinuations
• Reports must be submitted within the defined regulatory timeframes.

In Summary:

Ongoing compliance in Canada requires medical device companies to establish robust QMS procedures for distribution records, complaint handling, and mandatory problem reporting. These measures ensure regulatory alignment, patient safety, and readiness for Health Canada inspections.