Updated 25 October 2026
IVD distributors by country: 6,663 licensed establishments in 89 markets
The Bastion Hale Distributor Index lists 6,663 licensed establishments with in-vitro diagnostics in their registry records across 89 of the 124 markets in the Index: 869 independent distributors (a channel role and no manufacturing of their own), 1,953 manufacturers' own import or sales entities, 685 regulatory representatives and 3,120 manufacturers or exporters. 48 markets have their own page for IVD distributors, published where a market has 10 or more establishments in the segment. The records come from US FDA (openFDA), EUDAMED, MHRA UK, COFEPRIS Mexico and 23 other public sources, Index build of 25 October 2026.
This page covers in vitro diagnostics, laboratory diagnostics and diagnostic reagent distributors in 89 markets: the Index groups analysers, reagents, rapid tests and laboratory consumables in one segment. The same lists answer searches for in vitro diagnostics distributors and diagnostics distributors.
IVD distributors by country
Markets with their own page for IVD distributors, the most independent distributors first. Establishments counts every licensed firm with in-vitro diagnostics on record, manufacturers included.
| Market | Independent distributors | Establishments |
|---|---|---|
| Brazil | 295 | 748 |
| Saudi Arabia | 100 | 162 |
| Singapore | 98 | 247 |
| Israel | 97 | 145 |
| Tanzania | 47 | 131 |
| Mozambique | 43 | 56 |
| Qatar | 34 | 49 |
| United States | 22 a minimum: the US FDA registration database lists no distributors | 1,354 |
| Uganda | 16 | 28 |
| Cameroon | 12 | 22 |
| Bahrain | 12 | 15 |
| Austria | 10 a minimum: EUDAMED lists no distributors | 44 |
| Mexico | 9 | 890 |
| Italy | 7 a minimum: EUDAMED lists no distributors | 170 |
| Finland | 7 a minimum: EUDAMED lists no distributors | 38 |
| Belgium | 6 a minimum: EUDAMED lists no distributors | 47 |
| Poland | 6 a minimum: EUDAMED lists no distributors | 45 |
| Sweden | 5 a minimum: EUDAMED lists no distributors | 65 |
| Denmark | 5 a minimum: EUDAMED lists no distributors | 47 |
| Norway | 5 a minimum: EUDAMED lists no distributors | 17 |
| France | 4 a minimum: EUDAMED lists no distributors | 129 |
| Australia | 4 | 42 |
| Germany | 3 a minimum: EUDAMED lists no distributors | 316 |
| Canada | 3 | 104 |
| Spain | 3 a minimum: EUDAMED lists no distributors | 84 |
| China | 2 | 549 |
| United Kingdom | 2 a minimum: the MHRA device register lists no distributors | 114 |
| Ireland | 1 a minimum: EUDAMED lists no distributors | 37 |
| Hong Kong | 1 | 27 |
| Japan | None yet 2 on file, all segments | 99 |
| South Korea | None yet 2 on file, all segments | 84 |
| Netherlands | Not listed by EUDAMED 399 on file, all segments | 80 |
| Türkiye | Not listed by EUDAMED 344 on file, all segments | 75 |
| Taiwan | None yet 1 on file, all segments | 67 |
| Kenya | None yet | 61 |
| India | None yet | 53 |
| Switzerland | Not listed by the Swiss register (swissdamed) | 53 |
| Nigeria | None yet | 43 |
| Czechia | Not listed by EUDAMED 340 on file, all segments | 31 |
| Ghana | None yet 14 on file, all segments | 28 |
| Viet Nam | None yet | 24 |
| Malaysia | None yet 3 on file, all segments | 23 |
| Hungary | Not listed by EUDAMED 234 on file, all segments | 22 |
| Pakistan | None yet | 16 |
| Romania | Not listed by EUDAMED 421 on file, all segments | 14 |
| Thailand | None yet | 11 |
| Greece | Not listed by EUDAMED 253 on file, all segments | 10 |
| Portugal | Not listed by EUDAMED 168 on file, all segments | 10 |
Selling devices abroad? Get the Next 10 Markets report, €490
Smaller markets for IVD distributors
Markets with fewer than 10 establishments in the segment. Each link opens the country page, where the segment table shows the count.
What the segment covers
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
Guides for this step
Questions about IVD distributors
Which countries have the most IVD distributors?
By independent distributors in the Index: Brazil (295), Saudi Arabia (100), Singapore (98), Israel (97) and Tanzania (47). By all licensed firms with in-vitro diagnostics on record, the largest markets are the United States (1,354), Mexico (890) and Brazil (748). Index build of 25 October 2026.
How many IVD distributors does the Distributor Index list?
The Index lists 6,663 licensed establishments with in-vitro diagnostics in their registry records across 89 of the 124 markets in the Index. 869 of them are independent distributors (a channel role and no manufacturing of their own); the rest are manufacturers, their own sales entities or regulatory representatives. 48 markets have their own page for IVD distributors.
Does the Index cover laboratory diagnostics distributors and diagnostic reagent distributors?
Yes. The Index groups analysers, reagents, rapid tests and laboratory consumables in one segment, so in vitro diagnostics, laboratory diagnostics and diagnostic reagent distributors are counted in the same country lists. Profiles list the makers each distributor represents where the registry names them.
How do I find an IVD distributor in a specific country?
Open the country in the table on this page, then check the roles, principals and registration counts of the top establishments. Or search the Index for your device and markets, free, no sign-up.
Is there a list of IVD suppliers by country?
Yes. This page lists 6,663 licensed firms with in-vitro diagnostics on record in 89 markets, and 48 of those markets have their own page. Suppliers that import, distribute or wholesale count as independent distributors where they do not manufacture; manufacturers and their own sales entities are counted separately. Index build of 25 October 2026.
Other disciplines
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 3,184 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 1,180 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 1,033 establishments, last seen 23 October 2026. Public register.
- Mexico COFEPRIS medical device registrations (registros sanitarios): 833 establishments, last seen 23 October 2026. Mexican government publication.
- Brazil ANVISA medical device registrations, open data portal: 740 establishments, last seen 23 October 2026. Brazilian government open data.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 644 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Singapore HSA medical device dealer licences and registers, data.gov.sg: 236 establishments, last seen 23 October 2026. Contains information from data.gov.sg made available under the Singapore Open Data Licence version 1.0.
- NUPCO public tender award lists, Saudi Arabia: 160 establishments, last seen 23 October 2026. Public tender records. A procurement signal, not a licence register.
- Tanzania TMDA registered and notified medical devices and licensed device premises: 131 establishments, last seen 25 October 2026. Public register.
- Israel Ministry of Health medical device register (AMAR): 122 establishments, last seen 23 October 2026. Public register.
- Kenya Pharmacy and Poisons Board register of medical devices and IVDs: 61 establishments, last seen 25 October 2026. Public register.
- Mozambique ANARME list of authorised medical devices and IVDs: 56 establishments, last seen 25 October 2026. Public register.
- Qatar Monaqasat government tender award notices, Ministry of Finance: 49 establishments, last seen 25 October 2026. Public tender records. A procurement signal, not a licence register.
- Nigeria NAFDAC Greenbook, registered medical devices: 43 establishments, last seen 25 October 2026. Public register.
- Ghana FDA products register, licensed importers and storage facilities: 28 establishments, last seen 25 October 2026. Public register.
- Uganda Government Procurement Portal signed contracts for medical supplies: 28 establishments, last seen 25 October 2026. Public procurement records from 2014 to 2019. A procurement signal, not a licence register.
- Australia TGA ARTG sponsors, Australian UDI Database public download: 23 establishments, last seen 23 October 2026. Australian government public data.
- Saudi Food and Drug Authority licensed establishments list, medical devices: 20 establishments, last seen 23 October 2026. Public register.
- Cameroon ARMP public contract award listings: 16 establishments, last seen 25 October 2026. Public procurement records. A procurement signal, not a licence register.
- Bahrain National Health Regulatory Authority medical device registration list: 15 establishments, last seen 23 October 2026. Public register.
- Oman Ministry of Health approved medical device establishments: 8 establishments, last seen 23 October 2026. Public register.
- Rwanda FDA medical device register and licensed device wholesalers: 4 establishments, last seen 25 October 2026. Public register.
- UAE Ministry of Economy register of commercial agencies, open data: 3 establishments, last seen 25 October 2026. Open data, reuse allowed with attribution to the Ministry of Economy website.
- Côte d'Ivoire AIRP licensed establishments and medical device registrations: 1 establishment, last seen 25 October 2026. Public register.
- Botswana BoMRA licensed device wholesalers and exempted device suppliers: 1 establishment, last seen 25 October 2026. Public register.
- Morocco AMMPS register of medical device establishments: 1 establishment, last seen 25 October 2026. Public register.
- Tunisia DPM register of medical device importers: 1 establishment, last seen 25 October 2026. Public register.
- Company website (the establishment's own public site): 260 establishments, last seen 25 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.