Health Canada publishes a classification tool for medical devices. It requires you to already know your product is a device. That is exactly where this check begins.
Four dedicated paths, one per product family. You get a preliminary orientation on screen, sourced line by line to the regulation, before anyone asks you for anything. A confidentiality undertaking signed personally by our president is available before you answer the first question, and you never have to name your molecule: if it is a generic, name its equivalent.
Do you need a Canadian entity to sell in Canada?
This is the first question every foreign manufacturer asks, and the answer is different for each product family. It is also counter-intuitive, which is why so many companies are misinformed. Everything below comes from the regulations themselves.
| Product family | Canadian entity | Product authorization held by | Activity authorization held by |
|---|---|---|---|
| Medical device, Class II to IV | Not required | Medical device licence, held by the manufacturer directly, foreign or not. Sections 26 and 33. | MDEL for the importer or distributor. Manufacturer exempt for its own devices, s. 44(2)(c). |
| Medical device, Class I | Not required | No licence. | MDEL, unless the manufacturer sells only through an MDEL holder. |
| Pharmaceutical drug | Required in practice | DIN, held by the manufacturer even at a foreign address, provided the Canadian importer is named. | DEL held by the Canadian importer. Buildings must be in Canada, s. C.01A.005(1)(g) and (h). |
| Natural health product | Required per policy | Product licence and NPN. A foreign applicant names a representative in Canada for notices, s. 5(b). | Site licence for the importer, with a quality assurance report. |
| Cosmetic | Required | None. Notification within 10 days of first sale, s. 30(1). | None, but the notification demands a name and address in Canada, s. 30(2)(f). |
There is no general regulatory agent status in Canadian law, unlike the European Authorised Representative or the U.S. Agent. What exists is fragmented: cosmetics have the only true responsible person in Canada, natural health products have a representative for notices only, and drugs have none at all.
Health Canada fees in force 1 April 2026
Fees are adjusted every 1 April and rounded up to the dollar. The figures below come from the annual adjustment notice published in the Canada Gazette on 6 December 2025, not from the schedules of the Fees Order, which still show phase-in amounts.
| Fee | Amount |
|---|---|
| Medical device establishment licence, MDEL | 5 519 $ |
| Class II device licence application | 643 $ |
| Class III device licence application | 14 163 $ |
| Class III, clinical diagnostic device, near patient | 30 169 $ |
| Class IV device licence application | 30 713 $ |
| Annual right to sell, Class II to IV | 460 $ |
| DIN application on a labelling standard | 1 945 $ |
| New active substance submission | 616 593 $ |
| Drug establishment licence, import | 38 916 $ |
| Each foreign building on the licence | 1 107 $ |
| Natural health product licence | No fee in force |
| Cosmetic notification | Free |
Questions we are asked every week
Can a foreign manufacturer hold a Canadian medical device licence?
Yes. Section 26 of the Medical Devices Regulations requires that the manufacturer hold the licence, and section 33 expressly contemplates an application from a manufacturer of a country other than Canada. No Canadian entity is required for the licence itself.
Do I need a Canadian company to sell a drug in Canada?
In practice yes, but not for the reason most people think. You can hold the DIN from a foreign address provided you name your Canadian importer. What you cannot hold is the establishment licence, because the regulation requires the buildings listed on it to be in Canada.
How much does a natural health product licence cost in Canada?
There is no cost recovery fee in force for natural health products. The proposal has been in consultation since 2023 and nothing has been published in Canada Gazette Part II. The 2026 to 2028 regulatory plan contains no fee regulation for this family.
How long does a DIN take?
For a DIN on a labelling standard, the published performance standard is 60 calendar days of screening followed by 60 calendar days of review. Budget 120 days, not 60. For a new active substance, 45 days of screening then 300 days of review.
Is my product a cosmetic or a drug?
It depends on what your label claims, not on what the product contains. Under section 2 of the Food and Drugs Act, cosmetics and drugs are both defined by what a product is represented as. A single therapeutic word moves your product out of the cosmetic regime entirely.
What does Pharmaflow charge?
We work on a fixed-fee mandate, set in writing before you sign. Never hourly, never a block of hours. For ongoing upkeep we offer a four-year subscription, because a licence is not maintained on a twelve-month horizon.
This page is orientation, not a regulatory opinion. Health Canada makes the decision, not us and not this page. Every result from the check above is reviewed and confirmed by a regulatory specialist with a pharmacy degree before it becomes an answer you can act on. That review is free and commits you to nothing.
Have a regulatory specialist confirm your reading
Free scoping, no obligation. 514 880-1147