MDL, MDEL and MDSAP: Canada in Plain English

Canada is the market where otherwise well-prepared exporters lose the most time, because three separate things get folded into one phrase — "we have the Canadian certificate".

There is no such single certificate. There are three.

MDL: the licence for a product

A Medical Device Licence (MDL) is issued for a device, by Health Canada, after review of the submission. It belongs to the product, not to the shipment, and it is held by the manufacturer.

Only Class II, III and IV devices need one. This is the detail that trips people up: Class I devices do not receive an MDL at all.

MDEL: the licence for a company

A Medical Device Establishment Licence (MDEL) is issued to an establishment — the manufacturer, the importer, or the distributor — for the activity of importing or distributing.

Your Canadian customer, the one placing the purchase order, needs this. It is theirs to hold, not yours. If they do not have it, they cannot legally import your goods, whatever documents you send them.

This is the single most common reason a first Canadian shipment sits in a warehouse: the factory supplied a licence for the product, and the importer never obtained a licence for the company.

MDSAP: an audit programme, not a licence

The Medical Device Single Audit Program (MDSAP) is a single quality-system audit accepted by several regulators, including Health Canada. It replaces the older CMDCAS scheme.

It is not a marketing authorisation and it does not license anything. It is how a manufacturer demonstrates that its quality management system meets the requirements — one audit, recognised in several markets, instead of a separate audit for each.

If a supplier describes MDSAP as "our Canadian approval", they are compressing three different things into a phrase that will not survive a conversation with a regulatory consultant.

Who holds what

Where we stand

We hold an ISO 13485 certificate and a Canadian medical device licence for vaginal douches, earsyringes, enema kits, rectal syringes and endoscope insufflation bulbs.

One honest caveat, because it saves time: if the item you are buying is Class I in Canada, the document set your importer needs from us is different from the one a Class II buyer needs. Tell us the product and the class your importer is filing under, and we will confirm which documents apply before your customer starts the application — not after.

A five-line check before you quote

1.Which Canadian class is this device? (Ask, do not assume from the US classification — they are different systems.)

2.Does my importer hold an MDEL?

3.If Class II or above, does the manufacturer hold an MDL for this exact device?

4.Is the ISO 13485 certificate current, and does its scope cover this product family?

5.Is the label bilingual where required, and does the French text match the English?

The fifth one is not paperwork. A bilingual labelling error is a customs problem, and it is the cheapest thing on this list to fix early.