MDL vs MDEL: What Each Licence Actually Covers

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. One licence attaches to a device; the other attaches to a company. A buyer who keeps that distinction straight is very hard to mislead — and this guide is built to make it a reflex.

What is an MDL (Medical Device Licence)?

A Medical Device Licence is Health Canada’s authorization for a specific Class II, III or IV medical device to be sold in Canada for its stated intended use. It is held by the device’s manufacturer, carries a licence number, and appears as a public record in the MDALL database. For a treatment laser, the MDL is the licence that matters.

Under the Medical Devices Regulations, no person may import or sell a Class II, III or IV device unless the manufacturer holds a licence for that device^[3]. Class I devices are the exception — they require no MDL and never appear in MDALL — but most aesthetic and surgical lasers are higher-risk, energy-emitting devices that do require one. Read the class off the actual record; see device classes I–IV explained.

What is an MDEL?

A Medical Device Establishment Licence is a company-level permit. Health Canada issues it to importers and distributors of all device classes, and to manufacturers of Class I devices, to authorize that business activity. It does not review, approve or list any device. Health Canada states that an MDEL does not constitute approval of any device the holder imports or distributes.

That statement is the whole point. There is no product list behind an establishment licence, so an MDEL number can never be looked up to confirm a laser — there is nothing device-specific to find. The public MDEL listing shows a company, an address and its authorized activities, and nothing else^[2].

Side by side

What is MDALL, and how do you search it?

MDALL — the Medical Devices Active Licence Listing — is Health Canada’s free, public database of active Medical Device Licences for Class II, III and IV devices^[1]. It needs no login, and it is the single authoritative place to confirm a device licence. A vendor’s certificate, PDF or screenshot is secondary; the live record is the source of truth.

1. Open the MDALL Active Licence Search.
2. Search by one field — the licence number the vendor gave you is the strongest; the device identifier on the unit is next; device name or company name returns a partial list.
3. Open the record and confirm three things against the unit in front of you: the status is active, the licence holder matches the manufacturer on the label, and your model or device identifier appears in the record.
4. If nothing comes up in the active search, run the Archived Licence Search — a cancelled or archived licence means the device cannot legally be sold in Canada in that state.

The field-by-field walkthrough, status codes and red flags are in How to Verify a Health Canada Licence in MDALL.

Is there an “MDL certificate”?

Buyers often search for an MDL certificate to collect from the vendor. Treat that instinct carefully. What you want is the licence number and the licence-holder name, in writing, so you can open the live record yourself. A certificate image proves only that someone produced a certificate image. The MDALL record — active status, correct holder, your model — is the verification, and it costs nothing and takes about a minute.

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 in the public listing is a sensible second step for supply-chain confidence.

A related confusion comes from south of the border. A US FDA 510(k) clearance is a US market authorization and has no legal standing as a Canadian licence; a device can be accurately “510(k) cleared” and hold no Canadian MDL at all. Likewise, a CSA, cUL or IEC 60601-1 mark certifies electrical safety, not medical-device licensing. See FDA cleared vs approved vs registered vs listed for the US side.

A buyer’s checklist

• Ask, in writing, for the MDL number, the licence-holder (manufacturer) name, and the device identifier as it appears in MDALL.
• Look the record up yourself in MDALL; do not accept a screenshot.
• Confirm active status, licence holder, and your model in the record.
• Treat an MDEL number, an FDA clearance, or a safety mark as supplementary — never as the device licence.
• Keep a dated copy of what you found.

Verification is the start of diligence, not the end: what an active licence does and does not promise is covered in what “Health Canada licensed” means, and the commercial questions that follow — training, warranty, service — are in the used-laser buyer’s questions.