Health Canada Medical Device Licence (MDL): Classes, MDSAP, Fees and Process

For manufacturers that already run a strong quality system, Canada is often the most practical market to add after the United States and the EU. The system is risk-based, the dossier will look familiar, and there is a clear rule on quality system evidence: for Class II, III and IV devices, you need an MDSAP certificate. This guide explains how Health Canada classifies devices, which licence you need, what goes into an application, what it costs, and what you must keep doing after you are licensed.

The legal framework in brief

Medical devices in Canada are regulated under the Food and Drugs Act and the Medical Devices Regulations (SOR/98-282). Health Canada’s Medical Devices Directorate reviews licence applications, and the same regulator oversees post-market activities such as mandatory problem reporting and recalls. Devices are classified I to IV by increasing risk, using the classification rules in the regulations.

Two different licences: MDL and MDEL

Teams often mix up the two licences Health Canada issues, so it helps to separate them.

Licence	Applies to	What it covers
Medical Device Licence (MDL)	Class II, III and IV devices	The device itself: safety, effectiveness, labelling and quality system evidence
Medical Device Establishment Licence (MDEL)	Importers and distributors, and manufacturers of Class I devices	The company’s activities: documented procedures for distribution records, complaint handling and recall

A foreign manufacturer of a Class II, III or IV device holds the MDL in its own name and does not need an MDEL to sell its own licensed devices. Class I devices do not need an MDL, but whoever imports or distributes them generally needs an MDEL.

Classification

Canada uses 16 classification rules grouped by device type: invasive devices, non-invasive devices, active devices and special rules. Class I devices are the lowest risk and Class IV the highest. Familiar examples run from a simple reusable instrument in Class I to an implantable cardiac device in Class IV. Classification drives the evidence you submit and the fee you pay, so document the rule you applied and why. Our guide to device classification explains how to build a defensible classification rationale in the US and EU, and the same discipline applies here.

The MDSAP requirement

Since 2019, Health Canada has required a valid MDSAP certificate for licence applications and renewals for Class II, III and IV devices. The certificate must come from an auditing organisation recognised by Health Canada and must cover the Canadian requirements in its scope. A standalone ISO 13485 certificate, such as one issued only for EU purposes, is not accepted in its place.

Practical consequences:

• If you do not yet have MDSAP certification, schedule the audit early. It is usually the longest lead item.
• Make sure the certificate scope matches the devices you plan to license and names Canada.
• Keep the certificate valid. If it lapses, the licence can be affected.
• The MDSAP audit is based on ISO 13485:2016 plus the requirements of the participating regulators, so a company that already meets ISO 13485 and the US QMSR is well placed. See ISO 13485 and MDSAP audit readiness for preparation steps.

What goes into the application

The submission is made electronically through Health Canada’s enrolment and filing process. The content depends on class:

Class	Typical content
II	Device description and intended use, labelling, a declaration that safety and effectiveness requirements are met, MDSAP certificate
III	Everything for Class II, plus a summary of safety and effectiveness evidence, such as design validation, risk analysis, and where relevant clinical data, with supporting information available on request
IV	Class III content plus a full set of detailed evidence, including more extensive design, manufacturing, preclinical and clinical information

Much of this is material you already hold from a 510(k), PMA or technical file. Mapping your design controls outputs and risk management file to the Canadian requirements is usually faster than writing new documents. For devices in contact with the body, the biological evaluation will be reviewed.

Labelling

Labels must meet the content requirements in the regulations. Devices that may be sold to the general public need labelling in both English and French, so plan translations and review time. Keep Canadian labels under document control alongside your other regional versions.

Fees and review times

Health Canada publishes its fees and adjusts them each April. For the 2026 to 2027 fiscal year, the published licence application fees are about CAD 643 for Class II, CAD 14,163 for Class III and CAD 30,713 for Class IV, plus an annual right-to-sell fee of about CAD 460 for each licence holder. Licence amendments, near-patient IVDs and private label licences have their own fees. Confirm the current figures on the Health Canada fee page before budgeting.

Health Canada publishes service standards for review, commonly cited as about 15 days for Class II, 75 days for Class III and 90 days for Class IV for a complete application. These are targets for the review clock, not a guarantee of total elapsed time, because screening, questions from the reviewer and your response time all add to the schedule.

After you are licensed

• Annual licence review. Licence holders confirm their licences each year and pay the right-to-sell fee.
• Licence amendments. Significant changes, such as a change to the intended use, materials, design or manufacturing that affects safety or effectiveness, need an amendment before the changed device is sold. Our guide to device change control shows how to structure the change assessment that supports this decision.
• Mandatory problem reporting. Manufacturers must report incidents that could cause death or serious deterioration in health, with short timelines for serious risks. Align this with your complaint handling and CAPA process.
• Recalls. Recalls are reported to Health Canada. See recalls and field safety corrective actions.
• Records. Distribution and complaint records must allow you to trace affected devices.

A step-by-step plan

1. Classify the device under the Canadian rules and confirm whether it needs an MDL or only establishment licensing.
2. Check MDSAP status and book the audit if needed, making sure Canada is in scope.
3. Map existing evidence (design validation, risk file, clinical data, biocompatibility, software and electrical safety reports) to the class requirements.
4. Prepare bilingual labelling where required and review it with your regulatory and quality teams.
5. Submit the application and fee through Health Canada’s electronic process, and respond to reviewer questions promptly.
6. Set up post-market reporting, annual review and change control so the licence stays valid.

Common mistakes

• Applying with an ISO 13485 certificate that is not an MDSAP certificate.
• Letting the MDSAP certificate lapse or narrowing its scope after the licence is granted.
• Assuming an MDEL is enough for a Class II to IV device.
• Making a design or manufacturing change without assessing whether a licence amendment is needed.
• Planning the budget from last year’s fee schedule.

Frequently asked questions

Do I need a Canadian representative?

For a Class II to IV device, the manufacturer holds the licence and applies directly, so a local representative is not a legal requirement in the way it is in some other markets. In practice, many manufacturers use a Canadian regulatory contact, and importers and distributors need their own establishment licences.

Is MDSAP mandatory for Class I devices?

No. Class I devices do not need an MDL or an MDSAP certificate. The importer or distributor generally needs an establishment licence.

Can I use my FDA clearance or CE certificate for a Canadian licence?

Those approvals are not accepted as a substitute, but the underlying documents, such as test reports, risk files and clinical evidence, are usually reusable in a Canadian application.

How long does a Canadian licence take overall?

The review clock is short, but the whole project depends on how ready your MDSAP certificate and dossier are. If the certificate is in place and the file is organised, the application can be quick. If you need a new audit, plan for that first.

Fees, service standards and requirements change over time. The figures above reflect public information in November 2026 and are for training purposes. Confirm current requirements with Health Canada and your regulatory advisers.

Related reading

• Global market access beyond the US and EU: how Canada compares with other markets.
• ISO 13485 and MDSAP audit readiness: how to prepare for the audit Canada requires.
• US FDA medical device regulations: where much of your evidence will come from.
• Device change control: deciding when a change needs a new approval or licence amendment.

Talk to the AptSkill team

Preparing a Canadian licence or an MDSAP audit? Send us your device class, target markets and goal.