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Canada’s MDALL is one of the cleanest public verification tools in this series: free, no login, searchable by device name, company name, licence number or identifier. But it has a structural gap that catches buyers every time: Class I devices never appear there by design. And many panels sold legally in Canada without a Medical Device Licence are not in MDALL either — because they are imported as wellness devices, not medical devices. The difference between “not licensed” and “not required to be licensed” is the whole verification question. This guide walks it.
RedVance manufactures red light therapy panels in Shenzhen and supplies brands and distributors selling into Canada. This guide is method: apply it to any supplier’s Health Canada claim. Part of a market-by-market series indexed in our regulatory verification hub.
Canada’s four-class system and what MDALL covers
Health Canada classifies medical devices in four classes by risk level, and the licensing requirement differs by class:
| Class | Risk level | Licence required | In MDALL |
|---|---|---|---|
| Class I | Lowest | No MDL — establishment licence only | No |
| Class II | Low-moderate | Medical Device Licence (MDL) | Yes |
| Class III | Moderate-high | MDL | Yes |
| Class IV | Highest | MDL | Yes |
The consequence for buyers: a search of MDALL that returns nothing for a device does not prove the device is unlicensed. It may be a Class I device with no MDL requirement. It may also be a Class II device without the licence it should have — which is why the follow-up question matters. Ask the supplier to state the device class and explain its licensing status, not just confirm whether it appears in MDALL.
How to search MDALL
- Ask the supplier for the MDL number and the licence-holder name as it appears in the MDALL record. A supplier claiming a Health Canada MDL who cannot produce a number has not substantiated the claim.
- Go to Health Canada’s MDALL portal at health-products.canada.ca. Free, no account required.
- Use the Active Licence Search first. Enter the MDL number, or search by company name, device name or device identifier.
- Confirm the licence status is active — the system colour-codes results: active records in black, obsolete in red.
- Read the device identifier and intended use on the record. Confirm the specific model you are buying is covered, and that the intended use matches the claims the supplier is making.
- Run the Archived Licence Search separately to rule out a cancelled or expired licence — a device that had a licence and lost it may still circulate.
MDL vs MDEL: two different things
One of the most persistent points of confusion in Canadian sourcing conversations:
- MDL (Medical Device Licence) — a product-specific licence for Class II, III and IV devices. This is what appears in MDALL. It authorises that specific device for sale in Canada.
- MDEL (Medical Device Establishment Licence) — a company-level licence required for importers, distributors and manufacturers of medical devices, including Class I. It authorises a company to handle medical devices — not a specific product.
A supplier holding an MDEL is not thereby licensed to sell an unlicensed Class II device. An MDEL is a company credential; an MDL is a product credential. They answer different questions and a buyer needs to know which is being claimed. The structural parallel is the US distinction between establishment registration and device clearance, covered in our US guide.
What drives the classification decision
Classification — and therefore whether an MDL is required — depends substantially on intended use and claims. Most red light panels are non-invasive, externally applied, and present a relatively low risk profile. When marketed with therapeutic claims, they are more likely to be classified as Class II medical devices requiring an MDL. When marketed as wellness or cosmetic products without therapeutic claims, they may sit outside that requirement.
Factors that influence the classification include power level, wavelength, depth of tissue penetration, area of use, and the specific health claims made. The same hardware can fall into different classes depending on how it is labelled and marketed — which means the classification decision is made at the point of marketing, not at the point of manufacture. This is the same claims-driven boundary as Australia, the US and the UK, and it means the brand putting claims on a Canadian listing carries the classification responsibility for those claims.
The broader claims framework is in our claims verification guide, and how claims interact with market access across four countries in our market comparison guide.
What MDALL does not tell you
- Nothing about device performance. A Health Canada MDL confirms licensing, not that the device delivers its claimed irradiance. Technical verification is a separate exercise — see our guide to reading an irradiance test report.
- Nothing about your private-label version. An MDL belongs to the licence holder for that specific device. A private-label version marketed with different claims may require its own licence assessment.
- Nothing about the manufacturer. The licence holder may be a Canadian importer or distributor, not the factory. The factory may appear in a separate manufacturer field — verify both entity and factory using the methods in our business registration guide and factory verification guide.
The Canada verification checklist
- Established whether the intended Canadian claims require an MDL — wellness or therapeutic?
- If MDL claimed: obtained the MDL number and licence-holder name from the supplier.
- Searched MDALL Active Licence Search and confirmed the result is active, device identifier matches, and intended use matches the intended claims.
- Run the Archived Licence Search to rule out a cancelled or expired record.
- Distinguished between MDL (product) and MDEL (company) in any supplier claim.
- If device absent from MDALL: asked supplier to state the class and explain the licensing basis.
- Confirmed the licence holder entity and whether it is the manufacturer or a Canadian importer.
- Obtained technical documentation independently of regulatory status.
Other markets in this series: USA, EU, UK, Australia, Singapore, Malaysia, Brazil and Mexico. Terms are defined in our glossary.
What a manufacturer can do about it: state the Canadian device class and licensing basis rather than implying MDL status that does not exist, provide the MDL number and licence-holder name where an MDL is held, distinguish clearly between MDL and MDEL in any compliance claim, tell private-label buyers whether a new licence assessment is required for their version, and supply technical documentation separately from regulatory status. A supplier who can explain the Canadian classification clearly is more useful than one who vaguely implies approval.
Frequently asked questions
How do I verify a supplier’s Health Canada or MDALL claim?
Ask for the Medical Device Licence (MDL) number and the licence-holder name as it appears in the MDALL record. Search Health Canada’s Medical Devices Active Licence Listing at the health-products.canada.ca portal — it is free and requires no account. Confirm the licence status is active, the device identifier matches what you are buying, and the intended use on the record matches the claims the supplier is making. Run a separate archived licence search to rule out a cancelled or expired record.
What is MDALL?
MDALL, the Medical Devices Active Licence Listing, is Health Canada’s official public database of active Medical Device Licences for Class II, III and IV devices. It is free, requires no login, and can be searched by device name, company name, licence number or device identifier. Class I devices do not require a Medical Device Licence and never appear in MDALL — they are handled through a separate establishment licensing system.
Why do Class I devices not appear in MDALL?
Health Canada’s classification system requires a Medical Device Licence, and therefore MDALL registration, only for Class II, III and IV devices. Class I devices, considered the lowest risk, require establishment licensing rather than a product licence. A product not appearing in MDALL may legitimately be a Class I device — or it may be a higher-class device without the required licence, which is why asking the supplier to state the class and explain why it is not in MDALL matters.
What determines whether a red light panel needs a Medical Device Licence in Canada?
The intended use and the claims made about it. A device marketed with therapeutic purposes — reducing a condition, treating a health problem, or stimulating a biological response in clinical terms — is more likely to be classified as a medical device requiring a licence. A product marketed as a wellness or cosmetic product without therapeutic claims may sit in a different category. Classification also depends on factors including power level, wavelength, depth of penetration and area of use.
Can a red light panel be legally sold in Canada without being in MDALL?
Yes. Many panels are sold legally in Canada as wellness devices without a Medical Device Licence, because they are not marketed with therapeutic claims that would pull them into Class II or above. This is the same claims-driven boundary that exists in Australia and the United States. Absence from MDALL only contradicts a claim when the supplier specifically asserted that the device holds a Health Canada Medical Device Licence.
What is the difference between an MDL and an MDEL in Canada?
An MDL, or Medical Device Licence, is a product-specific licence required for Class II, III and IV medical devices. An MDEL, or Medical Device Establishment Licence, is a company-level licence required for importers, distributors and manufacturers of medical devices, including Class I. They are different requirements, and a company holding an MDEL is not thereby licensed to sell unlicensed Class II devices.
Ask what applies to your Canadian listing
Tell us the claims you intend to make in Canada and we will tell you what documentation we can supply and what the classification basis is for those claims. Where the device does not hold a Canadian MDL, we say so and explain why — that is more useful than a vague implication of compliance.
Ask about Canadian documentation →