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 Regulations will 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, United Kingdom, and Australia.
  2. MDEL applicants and holders will be required to provide a list of suppliers to Health Canada for the medical devices they import or distribute in Canada, replacing the prior voluntary regime.
  3. There will be explicit provisions to reinforce existing requirements for MDEL holders to establish, implement and maintain documented procedures for various safety-management activities.
• Businesses that hold MDELs and/or medical device licences (MDLs) should consider how these changes will affect their operations.

Key amendments introduced by the Regulations

1. New MDEL exemption for foreign distributors

Until now, both a foreign distributor and its Canadian importer required an MDEL to import a medical device into Canada, a duplication that added cost and delay, and was out of step with other key jurisdictions. Once the amendments are in force, a foreign distributor that sells into Canada through a Canadian importer that already holds an MDEL no longer needs its own MDEL. Health Canada has indicated that having a licensed importer in Canada is sufficient to manage safety and traceability issues.

Persons who import medical devices without an MDEL under an exemption in the Regulations (e.g., Canadian retailers or healthcare facilities) will continue to be required to ensure that the foreign distributor they are importing from holds an MDEL.

A concern raised during the consultation period was that, with foreign distributors no longer licensed, the burden of recalls would fall solely on importers. In the Regulatory Impact Analysis Statement accompanying the amendments, Health Canada clarified that the importer has always been the entity responsible for conducting recalls, and that removing licensing requirements for foreign distributors will not change recall obligations nor its oversight.

For multinational businesses, the change will be an opportunity to simplify their Health Canada licensing obligations as affiliated foreign distributors will no longer need their own MDEL.

2. Supplier list now mandatory

MDEL holders are now required to provide a supplier list to Health Canada, which includes the name and address of every person, other than the manufacturer, who sells a medical device to the MDEL holders. Supplier lists must also include the risk classification of the devices sold to the MDEL holders. The supplier list must be provided as part of the application for an MDEL and then updated each year during the annual licence review process. Any MDEL application that is pending when the amendments to the Regulations come into force must be updated to include supplier information before an MDEL will be issued.

This mandatory requirement replaces the voluntary regime that has been in place since February 2020. Health Canada has indicated that collecting supplier information will allow it to maintain visibility over foreign distributors that will no longer need to hold an MDEL.

Since supplier relationships are generally considered to be commercially sensitive information, Health Canada has indicated that it will treat the information as confidential business information.

3. Documented procedures become an explicit, enforceable standard

The Regulations currently require MDEL applicants and holders to attest to having documented procedures in place to manage health and safety risks relating to the importation and distribution of medical devices in Canada. However, Health Canada indicated that it has repeatedly found such procedures to be missing, incomplete or out of date when they are reviewed during an inspection.

The amendments to the Regulations will remove the attestation requirement, and instead explicitly require MDEL holders, including manufacturers, importers, and distributors, to establish, implement, and maintain documented procedures for safety-management activities, including the maintenance of distribution records; incident reporting; provision of information concerning any serious risk of injury to human health; handling, storage, delivery, installation, and corrective action; and servicing of devices (if applicable).

Health Canada has not set out a prescribed format, nor content, for the documented procedures. Health Canada has noted that manufacturers of Class II-IV devices that already maintain a quality management system under MDSAP/ISO 13485 will likely already be in compliance with these obligations.

Updates to Health Canada’s guidance documents

Health Canada will update the following guidance documents to reflect the changes that will be introduced by the amended Regulations. The updated guidance documents will come into effect on December 14, 2026, when the amended Regulations come into force.

1. Guidance on Medical Device Establishment Licensing (GUI-0016)
2. How Health Canada Inspects Medical Device Establishments (GUI-0064)
3. MDEL Application Instructions (FRM-0292)
4. Risk Classification Guide for Medical Device Establishment Inspections (GUI-0079)

What’s next

Businesses have about six months to prepare before the amendments to the Regulations come into force on December 14, 2026. Businesses that hold MDELs and/or MDLs may consider

• assessing whether a foreign distributor could allow its MDEL to lapse (i.e., if the Canadian importer has an MDEL);
• reviewing supplier and distribution agreements to ensure that they permit disclosure of supplier identities to Health Canada;
• confirming that any MDEL applications pending when the amended Regulations take effect include the required supplier information; and
• auditing their internal standard operating procedures to ensure that they are documented, up to date and complete for compliance with the new explicit requirements relating to documented procedures.