Medical Device Establishment Licence Changes

Summary#

The federal government has published proposed Regulations Amending the Medical Devices Regulations (Establishment Licences). Health Canada says the changes would reduce duplicated licences for foreign suppliers, require importers and distributors to give a yearly list of their suppliers, and make safety-related procedures explicitly mandatory. The proposal was published on November 8, 2025 and is open for comment for 70 days; the changes would take effect six months (180 days) after registration if adopted.

What it does#

• Removes the rule that a Canadian importer with a licence must import only from a foreign distributor who also holds a licence. Persons that do not hold a licence (for example, retailers and health care facilities) would still have to verify that the foreign distributor they use holds a licence.
• Requires every applicant or holder of a medical device establishment licence (MDEL) to provide supplier information (name, address, and device class supplied) when applying and to update it once a year at the annual licence review.
• Makes explicit that manufacturers, importers, and distributors must establish, implement, and maintain written procedures for key safety-management activities, including:
  • maintaining distribution records;
  • incident reporting and reporting serious risks to health;
  • handling, storage, delivery, installation, servicing, and corrective actions;
  • complaint handling and recalls (already explicit).
• Removes the need to list medical specialities for each manufacturer in licence applications.
• Requires the annual licence review to be submitted before April 1 of each year with any updates to the information in the application.

Who's affected#

• Canadian importers and distributors who hold or apply for a medical device establishment licence (about 2,300 businesses). About 800 already give supplier lists voluntarily; roughly 1,500 would be newly required in the first year.
• Foreign distributors: some would no longer need an MDEL if they sell only to a licensed Canadian importer. Health Canada surveyed foreign MDEL holders (the survey returned 25 responses).
• Manufacturers of Class II–IV devices: largely unchanged because many already meet quality-management standards (ISO 13485).
• Retailers and health care facilities: still exempt from holding an MDEL, but must ensure the foreign supplier they buy from holds one.
• Small businesses: about half of MDEL holders who responded to a past survey identified as small businesses. Health Canada estimates that roughly $840,000 (present value over 10 years) of the implementation cost would fall to small firms.

Why it matters#

• Reduces duplicated licensing and paperwork for some foreign suppliers and their Canadian importer partners. That could lower costs and make it easier for some suppliers to sell into Canada.
• A mandatory, yearly supplier list gives Health Canada better visibility of who is supplying devices to the Canadian market. That should help trace problems and speed targeted recalls or enforcement when safety issues appear.
• Making documented safety procedures explicitly required aims to close gaps found in inspections and give businesses clearer legal expectations about how to manage device safety once products are on the market.
• Costs and savings: Health Canada estimates total monetized costs of about $1.8 million (present value) over 10 years for implementing supplier reporting and related work. The department also expects to forgo roughly $333,000 in annual fees from foreign distributors that would no longer need licences; a separate estimate put benefits to foreign MDEL holders at about $2.3 million (PV) over 10 years, but those foreign benefits are not counted in the Canadian cost–benefit total.
• The changes are intended to align Canadian practice more closely with other jurisdictions (for example, the United States, the European Union, United Kingdom, and Australia) while keeping or improving the ability to protect people’s health and safety.