Updated 25 October 2026
Who holds medical device registrations, market by market
In many markets the registration that lets a device be sold sits with a local company: a registration holder, authorised representative or sponsor. These pages name those companies, from each regulator's own register: 14,408 companies in 11 markets.
General information, not legal advice. Local law varies; take local counsel.
Registration holder lists
| Market | Local term | Listed | Also distribute |
|---|---|---|---|
| Brazil | ANVISA registration holders | 4,204 | 1,329 |
| Mexico | COFEPRIS registration holders | 2,689 | 9 |
| United Kingdom | UK Responsible Persons | 1,628 | 6 |
| Israel | Registration holders | 1,084 | 664 |
| Singapore | HSA registrants | 868 | 314 |
| Canada | Medical device licence holders | 543 | 0 |
| Australia | TGA sponsors | 521 | 70 |
| Saudi Arabia | SFDA authorized representatives | 278 | 254 |
| Türkiye | Authorised representatives | 65 | 7 |
| Bahrain | NHRA authorized representatives | 38 | 24 |
| European Union | EU authorised representatives | 2,490 | 289 |
Each list counts the companies a market's own register names as holder, authorised representative or sponsor. A company that holds a licence in another country is not counted here.
Not listed yet: United States, China, South Korea, Switzerland, Japan, India, Malaysia and Taiwan. The Index does not hold the register of holders for these markets yet, so it has no list to show.
Why the holder matters
The holder controls market access. If your distributor holds the registration, changing or adding a distributor runs through them. The article Who holds the registration sets out the options and the clauses to agree before the first order.
Next step
Registry data. Bastion Hale does not vouch for any establishment.