Which FDA-cleared devices have no Canadian licence?

The question

A manufacturer with an FDA clearance often asks the same thing: is anyone selling a device like ours in Canada yet? Distributors ask the reverse: which devices are cleared in the US but not licensed here?

Both questions can be answered, in part, from public data. The FDA publishes its 510(k) clearances. Health Canada publishes the Medical Devices Active Licence Listing, known as MDALL. Putting the two side by side shows where a cleared device has no active Canadian licence.

The method

We run this comparison with in-house tools built on the public FDA and Health Canada data. The steps are the same for any device category.

1. Define the category on the FDA side

We start from FDA product codes, using the Product Classification database to find the codes that describe the category. A narrow category gives a cleaner result than a broad keyword.

2. Pull the 510(k) clearances

For each product code, we pull clearances from the openFDA 510(k) endpoint, usually for a set decision-date range. Each record gives the device name, the applicant and the decision date. Duplicates and repeat clearances for the same device family are grouped.

3. Search MDALL for each manufacturer and device

MDALL can be searched by company and device name, and Health Canada also publishes it through an API. We search for each applicant, then for the device names it uses, and record any active licence we find.

4. Match, then review by hand

This is the step that takes judgement. The FDA and Health Canada do not share a device code, so there is no automatic join. Company names differ between legal entities and trade names, and device names change between markets. The tools propose candidate matches. A person reviews each one.

5. Report what is left

The output is a list of FDA-cleared devices for which no active Canadian licence was found, with the date the data was pulled and the limits below stated on the page.

Where the method stops

• Class I is invisible in MDALL. Class I devices do not need a medical device licence in Canada, so they never appear. A Class I device sold in Canada will look like a gap.
• 510(k) is not the whole US market. PMA approvals and De Novo grants sit in separate FDA databases, and many lower-risk devices are exempt from 510(k).
• MDALL shows active licences. A device that was licensed and later cancelled, or one that is under review today, will not show as licensed.
• Names do not line up. A Canadian licence may sit with a different legal entity in the same group, or use a different device name.
• A gap is not demand. No licence can mean nobody has tried, or that someone tried and decided the market was not worth it.

None of this makes the comparison less useful. It means every result needs a second look before anyone acts on it, and the report must say so.

What to do with the result

For a manufacturer, the list shows whether the Canadian category is open or crowded, and which competitors already hold licences. That feeds directly into classification and a licence application plan.

For an importer or distributor, it shows devices that would need a Canadian licence before they could be sold here. The manufacturer holds that licence, not the distributor, and the distributor needs its own establishment licence. See MDEL explained.

We can run this comparison for your category as part of a market intelligence scan, or you can start with the free one-page Market Intelligence Snapshot, which gives the headline numbers.