Last reviewed 2 November 2026 · SMEDTEC
Why one record per product matters
The same device is registered five times under five rulebooks. If each registration lives in its own list, a change to the device, its classification or its holder has to be remembered five times. Hanging every registration off one product record means a change is made once and its effect in each market is visible.
What to diary
The recurring items below are the ones teams most often miss. This is a planning summary; confirm the current requirement with each authority before relying on it.
Registration holders and recurring items by market
| Market | Who holds it | What to record | Recurring item to diary |
|---|---|---|---|
| European Union | Manufacturer, with an EU Authorised Representative if based outside the EU | EUDAMED actor registration (SRN), device registrations, certificates | Certificate expiry and surveillance audits |
| Great Britain | Manufacturer, with a UK Responsible Person if based outside the UK | MHRA device registrations and account details | Changes to registered devices and to the UK Responsible Person |
| United States | Manufacturer, with a US Agent for foreign establishments | FDA establishment registration and device listings | Annual registration renewal, October to December |
| Canada | Manufacturer holding the medical device licence | Medical device licence numbers by device | Annual statement to Health Canada before 1 November |
| Australia | Australian sponsor | ARTG entries | Annual obligations on each ARTG entry; check current TGA guidance |
A good fit for
- Manufacturers selling one product range into several of these markets
- Representatives and consultancies holding registrations on behalf of clients
Not the right tool for
- Filing registrations directly with authorities: SMEDTEC OS tracks them, the filing is done in each authority's own system