Canada Medical Device Regulation Country Report

Canada's medical device market is one of the most robust markets in the world. Devices are regulated by Health Canada and 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 Class II - IV medical devices sold in Canada must obtain Medical Device Licenses (MDLs) through the Therapeutic Products Directorate's Medical Devices Bureau, and are listed in the Medical Device Active License Listing (MDALL). Low-risk devices (Class I) do not require such licensing, but the companies must apply for a Medical Device Establishment Licenses (MDEL) with the Health Products and Food Branch Inspectorate.

Moderate and high-risk devices (Class II - IV) must also comply with ISO 13485 quality system requirements under the Medical Device Single Audit Program (MDSAP), which includes QMS requirements of the Canadian Medical Devices Regulations (CMDR).

Emergo can help you evaluate 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. Our country report for Canada covers the following issues:

  • Health Canada regulatory background
  • Product assessment based on the CMDR
  • Device classification based on Health Canada’s rules in the CMDR
  • Medical device licensing requirements
  • Labeling requirements
  • Costs and timeframes
  • Regulatory roadmap for Canada
  • Quality System requirements
  • Post-market surveillance requirements

Please contact us for more information about our Regulatory Overview Report for Canada.

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