Canada MDEL Reform in Force 14 December 2026: The Three Changes That Catch Exporters Out

On 17 June 2026 Health Canada published the Regulations Amending the Medical Devices Regulations (Establishment Licences), SOR/2026-110, in Canada Gazette Part II, together with four revised guidance documents. The amendments come into force on 14 December 2026 – the second phase of Medical Device Establishment Licence (MDEL) reform, exactly two years after the first phase took effect. Officially the package is about reducing burden and improving supply-chain visibility. In practice it removes a licensing obligation from one part of the chain and adds a disclosure obligation to another, and the two move in opposite directions for exporters.

Primary source
Canada Gazette, Part II – SOR/2026-110

MDL and MDEL: the distinction that catches most exporters

The two licences are routinely confused, and the confusion is expensive. An MDL is granted for a product; an MDEL is granted for a company’s activities in Canada. A manufacturer holding an MDL for a Class II device still needs an MDEL if it imports that device into Canada itself – but not if it sells to a Canadian importer that already holds one.

Applied to actual activities, the picture looks like this:

The conclusion that matters for Chinese manufacturers: if your device is Class II-IV and reaches Canada through a licensed importer or distributor, you normally do not need an MDEL. What you need is the MDL and a quality system certificate under MDSAP. The reform changes who in the chain needs a licence, and adds one disclosure duty you must support.

Change 1: foreign distributors no longer need their own MDEL

Under the old section 44(3), a Canadian importer had to verify that its supplier held an MDEL. That pulled every foreign distributor supplying Canada into the licensing net, creating a double-licensing situation that added cost and diverged from practice elsewhere.

The amended section 44(4) removes the verification duty in three situations: a licensed entity importing Class I devices from the manufacturer; an importer bringing in Class II, III or IV devices from the manufacturer; and an importer bringing in any device from a non-manufacturer while itself holding an establishment licence.

In one sentence: if your goods only go to a Canadian importer that holds an MDEL, you do not need a licence of your own. The boundary matters. If you sell directly to retailers, hospitals or other entities that have no MDEL, you still need one.

Change 2: procedures move from self-attestation into the regulations

Previously, section 45(g)-(i) only required applicants to attest on the application form that the relevant procedures existed. Health Canada found during inspections that a number of licence holders had missing or incomplete procedures – the commitment and the reality did not match. The amendment writes the obligations into the regulations and deletes the attestation route:

• Section 52(3): manufacturers, importers and distributors must each establish, implement and maintain a documented procedure for distribution records;
• Section 58: all three parties must establish, implement and maintain documented procedures for carrying out their activities;
• New section 58.1: manufacturers, importers and distributors of Class II / III / IV devices must have documented procedures for handling, storage, delivery, installation, servicing and corrective actions;
• Sections 59(3) and 59(4): documented procedures for reporting obligations;
• Section 61.2(4): documented procedures for providing information.

This is not a new set of obligations so much as an explicit restatement of existing ones. For a Class II-IV manufacturer already certified to MDSAP or ISO 13485, the procedures are normally covered by the quality system and the practical burden is small. For Class I manufacturers, importers and distributors, it is worth checking that the procedures can actually be produced on request rather than merely referenced in a manual.

Change 3: supplier information becomes mandatory

Since February 2020 Health Canada has been collecting supplier information on a voluntary basis. Take-up was poor – most MDEL holders did not provide it – leaving the regulator with limited visibility of import supply chains. The reform makes the information a condition of licensing:

• New sections 45(f.1) and 45(f.2): an MDEL applicant must provide the name and address of each non-manufacturer supplier and the class of devices it supplies;
• Section 46.1(1): the same information must be updated in the annual review application;
• Transitional provision: applications filed before the in-force date but not yet decided must add the two items using the form specified by the Minister;
• The information is treated as Protected B commercial confidential information.

Practically, your Canadian customer will come back to you asking for company details it did not previously need in writing. Having a standard English information pack ready – legal name, registered address, product list with the corresponding Canadian class – removes a reason for the file to stall.

Four guidance documents have already been revised

• GUI-0016 – Guidance on Medical Device Establishment Licensing;
• FRM-0292 – instructions for completing the MDEL application form;
• GUI-0064 – Guidance on Medical Device Establishment Inspections;
• GUI-0079 – risk classification guidance for establishment inspections.

Note the timing gap. The new versions are already published, but the old ones remain valid until the regulations take effect on 14 December 2026. The intervening months are a transition period during which Health Canada says it will run an intensive compliance campaign, publishing notices and pushing guidance updates to licence holders.

What to do before 14 December 2026

Class II-IV manufacturer selling through a Canadian importer
You do not need an MDEL; keep the focus on the MDL and the MDSAP certificate. Prepare a standard English company information pack (legal name, registered address, product list with Canadian classification) that you can send to customers on request, and confirm with each Canadian customer whether it holds an MDEL and how it intends to report your details.

Chinese trading company contracting directly with Canadian customers
Decide first whether you still need an MDEL: selling only to licensed importers means no; selling directly to retailers, hospitals or end users means yes. If you took out an MDEL only to serve licensed importers, assess whether it is worth maintaining – the annual licence cost is real. If you keep it, note that the annual review date moves to 1 April and the supplier list must be added.

Company with a Canadian affiliate that imports on its own account
The affiliate remains a licence holder and now has to file supplier information and maintain the procedures in sections 52, 58, 58.1, 59 and 61.2. Check that the local quality system documents cover distribution records and handling, storage, delivery, installation and servicing – these are the areas most often documented at group level but not at Canadian entity level.

Sources

• Canada Gazette, Part II – Regulations Amending the Medical Devices Regulations (Establishment Licences), SOR/2026-110
• Health Canada – Medical Devices

GRZAN advises manufacturers and distributors on Canadian MDL/MDEL strategy, MDSAP readiness and the transition to the amended regulations.

This summary reflects SOR/2026-110 and the guidance published as of 14 October 2026. Health Canada may issue further guidance before the in-force date; confirm requirements against the current version of GUI-0016 and the regulations.