Health Canada has also released an updated GUI-0016 guidance, with resequenced sections and the senior official signature replaced by an Acknowledgement, mandatory from December 1, 2026.
On October 30, 2026, Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) Medical Devices Compliance Program issued an MDEL notice: further revisions were made to the Medical Device Establishment Licence (MDEL) application form FRM-0292 and the licensing guidance GUI-0016. This round of changes is not a minor wording tweak – it is a change in how applications are submitted.
1. Four Key Changes, One by One
The official notice explicitly lists the key changes in this round – four in total, the first three of which directly affect how companies complete the form:
1 – No more email submission; complete and submit online only
MDEL applications will no longer be submitted by email. The form can only be accessed, completed, and submitted through the official form link, with the entire process done online. For companies accustomed to the “download PDF – fill it in – email it” workflow, this is a structural change to the process.
2 – Sections 4 and 5 have swapped positions
After the change: Section 4 = Manufacturers and Suppliers, Section 5 = Sites.
Note: manufacturer names should only appear in Section 4 and must not be repeated in the site list.
3 – Senior official “signature” replaced by an “Acknowledgement”
The previous requirement for a senior official’s signature has been removed, replaced by an Acknowledgement completed with title/position, name, and date. The form is simpler, but the legal effect is not weakened – the substance of the declaration remains the same: the application information is true and accurate, and the required procedures have been established.
4 – Effective dates confirmed for the new form and new guidance
Both the new form and the new guidance take effect on December 1, 2026. Until then, continue using the current versions.
2. Timeline: A Corrected Date
This notice also contains an easily overlooked but important piece of information – it corrects the effective date stated in a previous notice. The corrected regulatory effective date is December 1, 2026, i.e., 180 days after registration in Canada Gazette, Part II on June 4, 2026. The date stated in the MDCP notice of June 17, 2026 was inaccurate; this notice prevails.
Key dates
2026-06-04
: The amended regulations were registered in Canada Gazette, Part II, starting the 180-day countdown.
2026-06-17
: The MDCP notice was published (its stated effective date was later corrected).
2026-06
: ROEB updated the MDEL licensing guidance and application form (part of the Phase 2 modernization work).
2026-10-30
: The new FRM-0292 completion instructions and the new GUI-0016 guidance were published, together with the notice.
2026-12-01
: The Phase 2 regulatory amendments take effect, and the new form and new guidance become mandatory. From that date, the new form must be used; until then, continue using the current PDF form.
3. What the New Form Looks Like: 6 Sections + 1 Appendix
The new FRM-0292 breaks the application into a fixed structure, and how much you fill in depends on the application type: new applications require the full form; amendments require re-checking the other sections for consistency after changing any one section; cancellation requires only Appendix A.
Section 1 – Applicant Information
Licence number, business identifier (6 digits), and former names (names related to mergers and acquisitions may be left blank).
Section 2 – Business Information
Legal name and operating/trade name; 2.1 licence address (PO boxes not accepted) and 9-digit Business Number (BN); 2.2 contact person; 2.3 mailing address; 2.4 billing address.
Section 3 – Activity Types
Check the import/distribution activities and the corresponding device classes. Only importing and distributing are licensable activities; manufacturing is not within MDEL licensing scope.
Section 4 – Manufacturers and Suppliers
Must not be left blank. At least one valid manufacturer is required for each device class; when there are many entries, use the Excel addendum (Section 4 Addendum), complete it, and upload it.
Section 5 – Sites
At least one building, which must be a physical address in the same country as the main address; check, item by item, the procedures established at each site.
Section 6 – Senior Official Acknowledgement
Completed by a person with direct knowledge of the documented procedures, providing title, name, and date, and making the acknowledgement.
Appendix A – MDEL Cancellation
There is also Appendix A: MDEL Cancellation. A cancellation must be submitted after all licensed activities have ceased, and can only be requested by the contact person or a person with senior official status.
4. Five Application Types – Choose the Right Entry Point
The first multiple-choice question on the new form is the “application type”. Choosing the wrong type sends your materials down the wrong process and directly affects processing time:
New
A first-time application, or a re-application after a licence has been cancelled.
Notification
Changes to the company name/address, or to the contact person’s name, position, or contact details, must be submitted within 15 calendar days.
Amendment
Changes to the manufacturer list, activities, or device classes should in principle be submitted with the Annual Licence Review (ALR); they may also be submitted early using FRM-0292, but the window is April 1 to mid-November each year.
Amendment to Terms and Conditions
A request to modify conditions previously imposed on the licence (Section 48.1 of the Regulations).
Cancellation / Reinstatement
Cancellation after all activities have ceased; reinstatement of a suspended licence.
Note: Notifications, amendments, and cancellations are free of charge; new applications, reinstatements, and the Annual Licence Review (ALR) require a fee. Small business fee relief requires that registration with valid status be completed at the time the application is submitted – completing it afterwards has no effect.
5. Six Points Where Companies Most Often Go Wrong
1
Putting manufacturers in Section 5.
Under the new rules, manufacturers appear only in Section 4; a manufacturer name in the site list is in the wrong place.
2
Using a PO box as an address.
Both the licence address and site addresses must be actual physical addresses.
3
Listing sites in other countries.
Sites must be in the same country as the company’s main address – a licence with a Canadian address may only list sites within Canada.
4
Device classes not matching manufacturers.
Every class checked in Section 3 must have a corresponding valid manufacturer in Section 4; for Class II/III/IV devices, also verify the manufacturer’s name, address, and 6-digit business identifier in the MDALL database.
5
Deleting old entries outright.
When amending, mark manufacturers/sites that are no longer used as Inactive rather than deleting them.
6
Forgetting the Annual Licence Review.
The condition for a licence to remain valid is – submit a complete ALR application before April 1 each year, and keep records of the submission for reference.
Official Links
Original notice: Updates to FRM-0292 and GUI-0016 (2026-10-30)
canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/updates-application-form-0292-gui-0016.html
New form and instructions: FRM-0292 online form + Instructions (effective 2026-12-01)
forms-formulaires.alpha.canada.ca/en/id/cmtlsi5yl001301x5dqjr6yxg
New guidance GUI-0016 (published 2026-10-30, effective 12-01, replacing version 10 of 2024-12-14)
Official notice and guidance (Health Canada): canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/dec-guidance-medical-device-establishment-licensing-0016.html
Disclaimer
This article is a summary of publicly available information from Health Canada and is provided for reference only. It does not constitute legal or regulatory advice. Requirements, dates, and procedures may change; always rely on the official notices, forms, and guidance published by Health Canada, and consult qualified professionals where necessary.