A Certificate of Free Sale (CFS) is a document that confirms a specific medical device is compliant with Canadian laws and regulations and is legally sold within Canada. This certificate is commonly required when exporting medical devices to international markets.
What Is a Certificate of Free Sale?
Issued by Food, Health & Consumer Products of Canada (FHCP), the CFS serves as official documentation that a medical device:
• Is lawfully sold in the Canadian marketplace
• Meets Canadian regulatory requirements
• Is manufactured, packaged, or labelled in Canada under an active site license
This document provides essential verification for international regulatory authorities, supporting product registration and approval for import.
Who Can Request a CFS?
Medical devices that are legally sold in Canada may be eligible for a Certificate of Free Sale through FHCP. Applicants must demonstrate that the device complies with applicable Canadian regulatory requirements.
Need a Certificate of Free Sale for export?
If your medical device is sold in Canada and requires documentation for international distribution, create an account or log in to purchase a Certificate of Free Sale.
Get started quickly and easily. Open your free account today and streamline your certification process from start to finish.
