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 published guidance states the amendments come into force on 14 December 2026. The amendments contain no transition provision.

The amendments make three changes affecting holders of a Medical Device Establishment Licence: an exemption for certain foreign distributors, a requirement to submit and annually update supplier information, and the conversion of specified documented-procedure obligations from an attestation basis to an express regulatory requirement. The third of these will require implementation work at most establishments.

Foreign distributors that sell medical devices into Canada through a Canadian importer holding an active MDEL are no longer required to hold an establishment licence of their own.

The exemption is conditional on the Canadian importer holding an active licence. Establishments that import directly, without transacting through a licensed importer, remain subject to the licensing requirement and to the obligation to verify the licence status of their suppliers.

MDEL applicants are required to submit supplier information as part of the application. Licence holders must update that information annually at the licence review, which falls due before 1 April each year.

The practical effect is that supplier information must be maintained on a continuing basis rather than compiled in response to a request. Amended paragraph 45(f.2) requires that, for each supplier other than the manufacturer, the list record the risk classification of the devices being imported or distributed through that supplier. Establishments will require a current list mapping each supplier to the devices it supplies and their risk classification, an individual accountable for its accuracy, and a scheduled process for refreshing it in advance of the annual review.

The Regulations now expressly require establishments to establish, implement and maintain documented procedures. This obligation previously operated through attestation, under which the licence holder affirmed that procedures were in place without the procedures themselves being submitted or routinely examined.

Under the amended Regulations the procedures fall within the scope of inspection. An inspector may request them, review their content, and record a deviation where a required procedure is absent, does not describe the activity it governs, or is not being followed in practice.

Procedures newly made express by this amendment

For all MDEL holders, the amendment converts the following from an attestation-based expectation into an express requirement:

• Maintenance of distribution records
• Mandatory problem reporting
• Provision of information concerning serious risk of injury to human health

Establishments dealing in Class II, III and IV devices are additionally required to maintain express procedures covering handling, storage and delivery; installation and servicing; and corrective action.

Complaint handling and recall procedures are not newly created by this amendment. Health Canada's Regulatory Impact Analysis Statement for SOR/2026-110 notes that these two obligations were already express requirements before this instrument. They remain part of the documented-procedures regime and are unchanged in substance by this amendment.

Implications for existing arrangements

Establishments that have attested to procedures operating as established practice, rather than as controlled documents, will need to address the difference before the coming-into-force date. Where an activity is performed consistently but no current written procedure describes it, and no records evidence training on it, the establishment satisfies the attestation model without satisfying the amended requirement.

The requirement extends to establishment, implementation and maintenance. Documents alone will not discharge it. The establishment must also be able to demonstrate that the procedures are in use, through completed records and training documentation.

Readiness checklist

The following covers the obligations described above.

Implementation considerations

Three points arise repeatedly in preparation of this kind.

The first concerns timing. The amendments contain no transition provision, and the 180-day interval between registration and coming into force constitutes the implementation window.

The second concerns the content of procedures. A procedure should describe the activity as the establishment performs it. Procedures drafted to describe an intended or idealised process create a discrepancy between the documented and the actual activity, which is more difficult to address at inspection than an acknowledged absence.

The third concerns supplier information. The obligation recurs annually against a fixed date. Establishments should implement the refresh process at the same time as the initial list, rather than treating compilation and maintenance as separate exercises.

Guidance documents affected

Health Canada is expected to publish revised versions of the following when the amendments take effect. Establishments should review the revised versions against their own procedures on publication.

• GUI-0016
• FRM-0292
• GUI-0064
• GUI-0079