Canada’s medical device market, one of the world’s most robust, is regulated by Health Canada. Devices are classified according to a risk-based system, as in most other markets a manufacturer’s regulatory requirements in Canada depend on its device’s classification.
Manufacturers of most medical devices sold in Canada must obtain licenses through the Therapeutic Products Directorate’s Medical Devices Bureau, and also be listed in the Medical Device Active License Listing (MDALL). Many lowest-risk devices (Class I devices) do not require such licensing, but the companies must register with the Health Products and Food Branch Inspectorate using Medical Device Establishment Licenses (MDEL).
Moderate- and high-risk devices must also meet ISO 13485 quality system requirements plus the Canadian specific additions to the ISO 13485 standard in order to be marketed in Canada.
Let Emergo assist you in evaluating the Canadian medical device regulatory framework as it applies to your device(s)
Using our worldwide network of consultants, industry contacts and regulatory resources, Emergo can provide you with accurate and actionable analysis through our Global Regulatory Overview Report service. Our country report for Canada covers the following issues:
- Health Canada Regulatory Background
- Product Assessment based on Canadian Requirements
- Device Classification based on Health Canada rules
- Authorized Representation requirements for Canada
- Medical Device Registration Requirements
- Labeling Requirements
- Costs and Timeframes
- Regulatory Roadmap for Canada
- Post-market Surveillance Requirements
Please contact us for more information about our Regulatory Overview Report for Canada.