MDL vs. MDEL: Health Canada Device Licensing for Exporters to Canada (FAQ)

Direct Answer

Canada divides medical device market access into two licences. Class II–IV devices require a Medical Device Licence (MDL) before sale, applied for by the manufacturer directly to Health Canada. Any establishment that imports or sells devices in Canada must hold a Medical Device Establishment Licence (MDEL), and must complete its annual licence review by 1 April each year. Both licences sit under the Medical Devices Regulations (SOR/98-282): one governs the product, the other governs the establishment.

Prepared by the Ameli regulatory editorial team from the target regulator's public pages; the verification date is shown at the end of this page.

Key Requirements

Competent Authority

Health Canada, Medical Devices Directorate, under the Health Products and Food Branch — https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Products in Scope

Medical devices are classified by risk as Class I, II, III or IV, with classification rules set out in Schedule 1 to the Medical Devices Regulations. Class II, III and IV devices require an MDL before they may be imported or sold (section 36 of the Regulations); Class I devices do not require an MDL.

The MDEL covers all classes: except where an exemption applies under the Regulations, every establishment that imports or sells devices in Canada must hold one (section 44 of the Regulations).

Core Documentation

MDL (section 32 of the Regulations): device name, class, device identifier, manufacturer name and address as shown on the label, and the name and address of the manufacturing site. Class II applications additionally require evidence of a quality system compliant with CAN/CSA-ISO 13485. Class III and IV applications additionally require risk management documentation, pre-clinical and clinical evidence, and manufacturing and sterilisation information.

MDEL (section 45 of the Regulations): establishment name and address, the types of activities to be carried out, the device classes involved, and a list of the manufacturers and suppliers whose devices will be imported or distributed.

Licence Validity

MDL: there is no expiry date; Health Canada issues an authorisation date only and does not set a lapse date. However, the annual right-to-sell fee must be paid under section 77 of the Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124); non-payment can result in suspension of the licence.

MDEL: maintained on an annual basis. The annual licence review must be submitted by 1 April each year (section 46.1 of the Regulations); failure to submit by that date results in cancellation effective 1 April.

Local Representative

No. Canada does not operate a mandatory local representative system, and Class II–IV manufacturers outside Canada apply to Health Canada for the MDL directly. In practice, however, the product must be imported and sold through a Canadian importer holding an MDEL. A Class I manufacturer outside Canada that sells directly to Canadian retailers must itself hold an MDEL; where it sells only to customers holding an MDEL, it may be exempt.

Regulatory Detail

The Medical Devices Regulations (SOR/98-282) are made under the Food and Drugs Act (R.S.C. 1985, c. F-27). Official consolidated text: https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html

• Section 32 — information required in an MDL application
• Section 33 — applications by manufacturers outside Canada and language requirements
• Section 34 — amendments to a licence
• Section 36 — issuance of an MDL
• Section 44 — prohibition on importing or selling without an MDEL
• Section 45 — MDEL application
• Section 46.1 — annual licence review

MDEL guidance: Guidance on medical device establishment licensing (GUI-0016) — https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html

Import requirements: Class II–IV devices require both an MDL and an MDEL held by the importer. A distributor outside Canada that sells only to a Canadian importer holding an MDEL may be exempt from holding an MDEL. See Health Canada, Regulatory requirements for importing medical devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Review service standards (measured from acceptance, including three business days of administrative processing): Class II — 15 calendar days; Class III — 60 calendar days; Class IV — 75 calendar days. See Guidance on managing applications for medical device licences (2025): https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses/review-process.html

The MDEL annual licence review is processed within 120 calendar days of receipt of a complete application; fees are due within 30 calendar days of the invoice date.

Fees: section 77 of the Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124) sets the annual MDL right-to-sell fee. Rates are adjusted annually; the applicable amount is the one published for the current year, and no figures are quoted on this page. https://laws-lois.justice.gc.ca/eng/regulations/SOR-2019-124/FullText.html

Verification date: 2026-11-02

Frequently Asked Questions

If I hold only an MDL and no MDEL, can I sell in Canada?

No — you cannot import or sell on your own account. Once a Class II–IV manufacturer holds an MDL, the device must enter the Canadian market through a Canadian importer or distributor that holds an MDEL. If the manufacturer establishes its own Canadian entity to carry out import or sales activities, that entity separately requires an MDEL.

Does Class I require a licence at all?

No MDL is required, but an MDEL is usually needed. A Class I manufacturer outside Canada that sells directly to Canadian retailers must apply for its own MDEL; where it sells only to importers or distributors holding an MDEL, it may be exempt.

Does an MDL expire?

The licence itself carries no expiry date, but continued validity is conditional: payment of the annual right-to-sell fee, filing of amendments under section 34, and discharge of post-market obligations. Non-payment or non-compliance may lead to suspension or revocation.

What happens if the MDEL annual review is missed?

Health Canada cancels the licence on 1 April, and the establishment immediately loses its authorisation to import and sell. Reinstatement requires a new MDEL application under section 45 — a late submission is not sufficient.

Should a manufacturer outside Canada appoint a representative in Canada?

The Regulations do not impose a mandatory representative system, and the manufacturer may apply on its own. In practice, a Canadian entity capable of assuming MDEL obligations is still needed to handle importation, traceability and recall contact.

Does Canada recognise CE marking or FDA clearance?

No — they are not a substitute. Canada applies its own classification and review, and CE certificates and FDA clearance may form part of the technical file but cannot replace an MDL.

How Ameli Supports Clients

• Determining Class I–IV status against the classification rules in Schedule 1 to the Medical Devices Regulations, and issuing a pathway conclusion on whether the product requires an MDL, an MDEL, or both.
• Managing MDL amendment milestones, MDEL annual review deadlines and right-to-sell fee due dates on a digital platform, with alerts 90 days in advance.
• Breaking the information requirements of sections 32 and 45 into task lists that identify which document is provided by the manufacturer and which by the Canadian importer, so that neither side assumes the other is handling it.

Scope Limitations

• Ameli does not act as a Canadian importer or as the MDEL holder, does not submit MDL or MDEL applications on a client's behalf, and does not file as an agent or CRO.
• Ameli does not guarantee review outcomes or timelines, does not substitute for Health Canada in making classification or compliance determinations, and does not cite fee rates that have not been officially published.

Ameli (艾梅莉) is a digital platform for overseas registration managed by medical device companies, covering products, regulations, documents, tasks, submissions and certificates. It is not a CRO and not an agent. Facts on this page follow the official sources; any figure not publicly released is marked as not officially disclosed.