Amendments to the Medical Devices Regulations (Establishment Licences)

SOR/2026-110, Regulations Amending the Medical Devices Regulations (Establishment Licences), was registered on 4 June 2026 and published in Canada Gazette Part II on 17 June 2026. Health Canada's guidance states that the amendments come into force on 14 December 2026, and the instrument's only transitional provision, section 9, concerns establishment licence applications still pending on that date.

The amendments remove the requirement for importers holding a Medical Device Establishment Licence (MDEL) to import from foreign distributors that also hold one, require supplier information in every MDEL application and at each annual licence review, and make explicit the requirement for manufacturers, importers and distributors to establish, implement and maintain the documented procedures relevant to their safety management activities, in place of the attestations previously given in MDEL applications. They also repeal the requirement to provide information on medical specialities, and replace paragraph 45(j) so that it refers to the buildings where the procedures in sections 52, 58, 58.1, 59(3) and (4) and 61.2(4) are in place.

The Regulatory Impact Analysis Statement is explicit that the documented-procedure requirements "are not new and do not impose additional burden on stakeholders". It also records that, despite the attestations, Health Canada's inspection observations revealed that these procedures "are often lacking, that there are gaps in how procedures are documented and implemented, and that they may be out of date". It follows that the practical effect falls on establishments whose procedures are in those categories.

In the words of the Regulatory Impact Analysis Statement, "The MDR require both foreign distributors and their Canadian importers to hold an MDEL." Subsection 44(3) requires any person who imports a medical device to "ensure that the person from whom they import it holds an establishment licence", and new paragraph 44(4)(c) disapplies that duty for "a person who imports any medical device from a person other than the manufacturer of that device and who holds an establishment licence".

Foreign distributors therefore "will no longer be required to hold an MDEL, if selling through an MDEL holder". The relief does not reach every importer, because "Persons without an MDEL that import (i.e. retailers and health care facilities) will continue to be required to verify that the foreign distributor whom they import from holds an MDEL."

Every MDEL application will have to include, under new paragraph 45(f.1), "the name and address of any person, other than the manufacturer, who sells a medical device to the establishment for the purposes of importation or distribution", and under paragraph 45(f.2), for each of those persons, "the classes of the devices that are being imported or distributed". The requirement is framed as device classes for each supplier, not as a list of individual devices.

Licence holders provide the information again at the annual licence review, for which subsection 46.1(1) requires the holder of an establishment licence that is not suspended to submit an application "before April 1 of each year" and to include "the information and documents referred to in section 45, including any updates to the information or documents, as the case may be". The first review after the amendments come into force therefore falls due before 1 April 2027, roughly fifteen weeks after 14 December.

MDEL applicants have attested to having documented procedures in place under paragraphs 45(g) to (i), which the amendments repeal. The Regulatory Impact Analysis Statement says the amendments "eliminate the attestations for documented procedures" and "do not introduce a requirement for MDEL holders/applicants to submit their documented procedures for review". In place of the attestations, the Regulations now state who must establish, implement and maintain which procedures.

Who each requirement applies to

• Distribution records, subsection 52(3): the manufacturer, importer and distributor of a medical device.
• Investigation of the problems referred to in paragraph 57(1)(a), and recall, section 58: the manufacturer, importer and distributor of a medical device. The opening words change from "shall each establish and implement" to "must each establish, implement and maintain".
• Handling, storage, delivery, installation, servicing and corrective action, section 58.1: the manufacturer, importer and distributor of a Class II, III or IV medical device, "as applicable".
• Preliminary and final incident reports, subsections 59(3) and (4): the manufacturer and importer of a Class I device, and the manufacturer and importer of a Class II, III or IV device.
• Information concerning serious risk of injury to human health, subsection 61.2(4): "the holder of a medical device licence and the importer of a Class II, III or IV medical device".

Distributors are not covered by the incident-reporting procedures in section 59 or the information procedures in subsection 61.2(4). Manufacturers of Class II, III and IV devices are brought into the explicit provisions, and the Regulatory Impact Analysis Statement notes that they are "already explicitly required to establish, implement and maintain documented procedures as part of their quality management system (QMS) certification under the Medical Device Single Audit Program (MDSAP)".

Complaint handling and recall procedures are not created by the amendments. The Regulatory Impact Analysis Statement describes that requirement as "already explicit", and the change to section 58 makes the existing requirement to maintain those procedures explicit.

Format and content

The Regulatory Impact Analysis Statement states that the requirements "remain outcome-based, since Health Canada does not prescribe the format or content of the procedures and how they should be established, implemented or maintained". Version control, named owners and training records may be sound practice, but the amended Regulations do not require them.

Readiness checklist

The items in the checklist are requirements of the amended Regulations, each with its source. Each procedure listed must be established, implemented and maintained. Items that are good practice but not required follow separately below.

Good practice, not required by the Regulations

• Written procedures that describe each activity as it is actually performed, given that Health Canada's inspection observations report gaps in how procedures are documented and implemented.
• A periodic review so that procedures do not fall out of date, which the same observations also report.
• A named owner for the supplier information, and a refresh ahead of each annual licence review.
• For a foreign distributor relying on Change 1, a check that its Canadian importer appears on Health Canada's MDEL listing.
• A review of the updated guidance documents listed below against existing procedures.

Updated Health Canada guidance

Health Canada states that it has updated the following documents and that it "will replace existing guidance with these updated versions when it comes into force in December 2026".

• GUI-0016, Guidance on medical device establishment licensing
• FRM-0292, Medical device establishment licence application: instructions
• GUI-0064, How Health Canada inspects medical device establishments
• GUI-0079, Risk classification guide for medical device establishment inspections