Two acronyms sit one letter apart, and buyers routinely swap them in emails. The mix-up costs time: you ask a supplier for their MDL, they send back an MDEL, and a week disappears before anyone notices. What settles the confusion is knowing what each licence is attached to. A Medical Device Licence is attached to a product, and a Medical Device Establishment Licence is attached to a place and to the activity carried out there.
What is the difference between an MDL and an MDEL?
An MDL names the device itself — its class, its intended use and the manufacturer responsible for it. It travels through the market with the device. An MDEL names the establishment: the Canadian address from which an organization imports, distributes or sells devices, plus the activity it is authorized to perform there. An establishment licence is not product-specific, so one distributor can hold a single MDEL and move hundreds of devices under it, provided each device needing a product licence already has one.
The two licences sit with different parties. The distributor holds the establishment licence; the manufacturer or its Canadian representative holds the product licence. When a buyer asks whether a supplier is licensed in Canada, the answer depends on which question was meant.
| Question | MDL — Medical Device Licence | MDEL — Medical Device Establishment Licence |
|---|---|---|
| Attached to | A specific device and its intended use | An establishment and its activity |
| Typical holder | Manufacturer, or the importer owning it | Importer, distributor or seller in Canada |
| Scope | One device family | Every device the establishment handles |
| Transfers with the goods? | No | No |
| Who checks it | Buyers of Class II to Class IV devices | Clinics buying through a distributor |
Which one applies to your import?
If you bring devices into Canada and sell them onward, the establishment licence is the one that lands on your desk, because importing for resale is an activity that requires it. The product side is separate: for devices in Classes II to Class IV, a device licence must exist before the device can be sold here, and it is usually held by the manufacturer or by the importer that has taken on that role.
The trap is assuming one licence covers both. You can hold a valid establishment licence and still be unable to sell a given device legally, because no product licence for it exists in your name or the manufacturer's.
Does a private-label device need its own MDL?
Yes, and this is the point that clinics selling under their own brand most often miss. Putting your name on a device does not exempt it from the product licence path; it can pull you into it, because responsibility for labelling and intended use follows the licence holder rather than the factory that moulded the plastic. If you are private-labelling, confirm in writing who holds the device licence.
Intended use wording matters too. A licence covers a device together with a stated purpose, so if marketing copy drifts — describing an examination glove as a surgical glove, for instance — the claim and the licence no longer line up.
What should a clinic ask a supplier for?
Ask two questions in one email and the answers tell you which licence you are dealing with. First: what is the establishment licence number of the Canadian importer or distributor? Second: for this specific device, what is the device licence number and who holds it?
A device licence number can be looked up by device name in the searchable register the federal device regulator maintains, so a buyer can confirm a claim rather than accept it. Sterilization paperwork rewards the same habit: in Ontario, the RCDSO requires a biological indicator for each sterilizer on every day it is used.
Start with a BI 5-pack trial: CliniEco 24h Biological Indicator — 5-Pack Trial. The wider set of Canadian acronyms is unpacked in our MDL, MDEL, DIN and NPN glossary.
Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers.
Related reading
- Compliance log centre
- Medical device licensing in Canada: Class I vs Class IV
- How medical gloves are regulated in Canada
Frequently Asked Questions
Do I need an MDEL if I only import devices for my own clinic?
Not usually. Importing devices for your own use in delivering care is not the activity that triggers an establishment licence; importing for resale or distribution is. The moment devices are sold or distributed onward, the establishment licence question applies.
Can a device be sold in Canada without an MDL?
For devices in Classes II to Class IV, a device licence must exist before sale. Class I devices are handled differently and are not subject to the same product licence requirement, which is why the establishment licence carries more of the compliance weight for that class.
Who holds the MDL, the factory or the importer?
It depends on the arrangement. The licence sits with the party responsible for the device in Canada, which may be the manufacturer or an importer that has taken on that role. Ask for the licence holder's name in writing, not just the number.
Is an MDEL number the same as an establishment licence number?
Yes. MDEL stands for Medical Device Establishment Licence, so the number on the certificate is the establishment licence number for that Canadian address and activity.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
0 commentaire