MDEL and DIN look like interchangeable registration numbers, but they come from two different Health Canada systems — one for medical devices and one for drugs and disinfectants. Choosing which applies to a product is straightforward once you know what you are buying. This guide explains both systems and gives you a verification routine you can run before placing an order.
Two systems, two questions
Health Canada regulates products by category. Medical devices — including isolation gowns, examination gloves, and wound dressings — fall under the Medical Devices Regulations. Disinfectants, hand sanitizers with germicidal claims, and other antimicrobial products are regulated as drugs or natural health products, which is where DIN and NPN numbers come from.
Ask one question first: is this a device or a drug? A box of gloves is a device. A can of disinfectant wipes that claims to kill pathogens is a drug in Canada, because germicidal claims make it one.
What the acronyms mean
| Acronym | Full name | Applies to | Issued to |
|---|---|---|---|
| MDEL | Medical Device Establishment Licence | The establishment, not the product | Any Canadian business that imports or sells medical devices, including Class I manufacturers |
| MDL | Medical Device Licence | Individual Class II, III, and IV devices | A specific device before it may be sold in Canada |
| DIN | Drug Identification Number | Drugs, including disinfectants and antimicrobial hand products | A specific product formula |
| NPN | Natural Product Number | Natural health products | A licensed natural health product |
MDEL vs MDL: establishment versus device
An MDEL licenses the business. If a supplier imports isolation gowns and sells them to clinics, that supplier holds an MDEL issued by Health Canada. An MDL, by contrast, licenses the device itself. Class I devices such as many non-sterile gowns may be sold under an establishment licence alone, while Class II, III, and IV devices each need a medical device licence before they can be marketed in Canada.
DIN: the disinfectant number you will see most often
A DIN means Health Canada reviewed the product's formula, labelling, and efficacy data as a drug. Disinfectant wipes with a claim against bacteria or viruses carry a DIN, and the number appears on the label. The same logic covers antimicrobial hand sanitizers, which are drugs when they claim to kill germs, and NPN covers natural health products such as some antiseptic skin products.
An example: Aurelia disinfecting wipes display a DIN, which you can look up in Health Canada's Drug Product Database to confirm the product's registration. If a wipe label claims disinfection but shows no DIN, treat that as a red flag.
How to verify before you buy
Verification takes about two minutes per supplier and should be a standing step in your purchasing workflow:
- Check the device side. Search the supplier's name in Health Canada's Medical Devices Active Licence Listing (MDALL). A licensed establishment shows an active MDEL, and regulated devices show their own licence numbers.
- Check the drug side. For disinfectants and antimicrobial hand products, search the product name or the DIN printed on the label in the Drug Product Database (DPD).
- Ask for numbers, not assurances. Request the supplier's MDEL number and the device licence numbers for the products you order, then confirm them in the databases yourself.
- Watch for exemptions. Some products, such as certain Class I devices, do not carry an MDL. The establishment licence is still required.
What this means for your clinic orders
When you buy disposable isolation gowns or medical nitrile gloves, you are buying medical devices, so the supplier's MDEL is the number that matters. When you buy disinfecting wipes, the DIN on the label is the number that proves the germicidal claim was reviewed by Health Canada.
Documenting these numbers in your supplier files also helps during inspections. Public health and college inspectors routinely look at whether purchased products are licensed for their claimed use, so a short verification log — product, licence type, number, date checked — is a useful compliance habit.
FAQ
Q: What is an MDEL in Canada?
A: A Medical Device Establishment Licence. It is issued by Health Canada to any establishment that imports or sells medical devices in Canada, including Class I device manufacturers. It licenses the business, not individual products.
Q: Is a DIN required for disinfectant wipes?
A: Yes, when the wipes make germicidal claims. In Canada such products are regulated as drugs, and the DIN must appear on the label. Wipes sold only for general cleaning, with no disinfectant claim, fall outside that requirement.
Q: How can I verify a supplier has a Health Canada licence?
A: Search the company name in Health Canada's Medical Devices Active Licence Listing for an active MDEL, and check device licence numbers there as well. For disinfectants and antimicrobial hand products, search the DIN in the Drug Product Database. When in doubt, ask the supplier for the licence numbers and verify them yourself.
Regulatory details change; confirm current requirements with Health Canada or your provincial regulator before making compliance decisions.
Related reading: learn more about Canadian medical procurement in our business hub.
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