Clinical Education
MDL vs MDEL: What Each Licence Actually Covers
An MDL (Medical Device Licence) authorizes a specific Class II-IV device for sale in Canada. An MDEL is a company-level permit to import or distribute devices - Health Canada states it approves no specific device. Only an MDL verifies a laser.
Two licences, two different questions
Canada’s medical-device framework licenses two different things, and the acronyms are close enough that sales conversations blur them constantly:
| MDL — Medical Device Licence | MDEL — Medical Device Establishment Licence | |
|---|---|---|
| Licenses | A specific device (Class II–IV) | A company’s business activity |
| Answers | ”Is this device authorized for sale in Canada?" | "May this company import/distribute devices?” |
| Product list behind it | Yes — the licensed device record | None |
| Where to verify | MDALL public database | Health Canada’s establishment-licence listing |
Health Canada is explicit about the boundary: an MDEL “does not constitute approval of any specific medical devices imported or distributed by the MDEL holder.” There is no product list behind an establishment licence. It can never verify a laser.
The sales conversation where this matters
You ask: “Is this laser Health Canada licensed?” A confident answer arrives with a licence number — but it is an establishment number. Nothing false has technically been said, and yet your question has not been answered. The defence is one habit: device questions get MDL answers. Take the MDL number to MDALL and confirm the status is active and the licence holder and model match the unit in front of you.
That is also the standard we hold ourselves to. Every Pro 1 Laser platform’s MDL number and a direct link to its official Health Canada record are published on our Regulatory & Quality page — device-level verification, not an establishment number offered in its place.
Where each fits in a legitimate supply chain
Both licences appear in a healthy transaction: the device holds an MDL, and companies importing or distributing it hold MDELs for their business activity. Neither substitutes for the other. When evaluating a supplier, verify the device’s MDL first; checking the seller’s MDEL is a sensible second step for supply-chain confidence.
Related reading: device classes I–IV explained and what “Health Canada licensed” does and doesn’t mean.
Related devices
FAQs
A vendor gave me their MDEL number when I asked about the laser's licence. Is that an answer?
No — it answers a different question. The MDEL says the company is permitted to import or distribute medical devices as a business. It says nothing about whether the specific laser you are buying is licensed. Ask again for the device's MDL number, then verify it in MDALL against the licence holder, device name and status.
Does a legitimate supplier hold both?
Commonly, yes — the device carries an MDL held by its manufacturer or licence holder, and companies in the import/distribution chain hold MDELs for their business activity. The point is not that either licence is suspicious; it is that they answer different questions, and only the MDL verifies the device.
Can I check an MDEL too?
Yes. Health Canada publishes an establishment-licence listing where you can confirm a company's MDEL is active. It is a reasonable supply-chain check — just remember what it does and does not tell you about any particular device.
Why does this distinction keep coming up in laser sales?
Because an establishment number is easy to obtain relative to a device licence, and quoting it sounds like an answer. Grey-market importers in particular lean on 'we are Health Canada licensed' phrasing that refers to their establishment permit, not the device. The one-line defence: device questions get MDL answers.