Canada’s Amended Medical Devices Regulations: What Will Change In December

On June 17, Canada’s federal government published finalized amendments to the Medical Devices Regulations (Regulations) in the Canada Gazette, Part II. These amendments modernize the requirements relating to the importation and distribution of medical devices in Canada.

What you need to know

• The amendments to the Regulationswill come into force on December 14, 2026.
• These Regulations are largely unchanged from the proposed amendments that were published in the Canada Gazette, Part I (described in our bulletin, Potential changes to medical device establishment licensing under Canada’s Medical Devices Regulations).
• Once in force, the following key changes will be implemented in the Regulations:
  1. Foreign distributors will no longer be required to hold a medical device establishment licence (MDEL) to sell medical devices through Canadian importers that hold an MDEL. This change will bring Canada in line with other key jurisdictions, such as the United States, European Union,