Updated 25 October 2026

Who holds medical device registrations in Singapore

In Singapore the company that registers a device with HSA is its registrant. The Index lists 868 HSA registrants in Singapore from the HSA Singapore register, last read on 23 October 2026.

Medical device companies in Singapore: distributors, importers and makers

Who may hold a registration in Singapore

In Singapore the company that registers a device with HSA is its registrant.

Sources: HSA, Regulatory overview (medical devices).

HSA registrants in Singapore: top 50

Ranked by SMDR registrations and dealer licences. Each name opens its profile with roles, principals and sources.

  1. 1
    617 registrationsMaker's own entity
  2. 2
    594 registrationsMaker's own entity
  3. 3
    577 registrationsMaker's own entity
  4. 4
    512 registrationsMaker's own entity
  5. 5
    460 registrationsMaker's own entity
  6. 6
    368 registrationsMaker's own entity
  7. 7
    336 registrationsMaker's own entity
  8. 8
    334 registrationsMaker's own entity
  9. 9
    332 registrationsMaker's own entity
  10. 10
    320 registrationsMaker's own entity
  11. 11
    317 registrationsMaker's own entity
  12. 12
    306 registrationsMaker's own entity
  13. 13
    283 registrationsMaker's own entity
  14. 14
    256 registrationsMaker's own entity
  15. 15
    244 registrationsDistributor
  16. 16
    244 registrationsMaker's own entity
  17. 17
    241 registrationsMaker's own entity
  18. 18
    ZIMMER PTE. LTD.Singapore South East
    239 registrationsMaker's own entity
  19. 19
    236 registrationsMaker's own entity
  20. 20
    222 registrationsDistributor
  21. 21
    222 registrationsDistributor
  22. 22
    219 registrationsMaker's own entity
  23. 23
    218 registrationsDistributor
  24. 24
    207 registrationsMaker's own entity
  25. 25
    201 registrationsMaker's own entity
  26. 26
    199 registrationsMaker's own entity
  27. 27
    177 registrationsDistributor
  28. 28
    ALCON PTE LTDSingapore
    169 registrationsMaker's own entity
  29. 29
    160 registrationsMaker's own entity
  30. 30
    157 registrationsMaker's own entity
  31. 31
    156 registrationsMaker's own entity
  32. 32
    ARTHREX SINGAPORE, PTE. LTD.Singapore Central Singapore
    153 registrationsMaker's own entity
  33. 33
    150 registrationsRegulatory representative
  34. 34
    137 registrationsMaker's own entity
  35. 35
    137 registrationsMaker's own entity
  36. 36
    133 registrationsDistributor
  37. 37
    130 registrationsDistributor
  38. 38
    125 registrationsRegulatory representative
  39. 39
    119 registrationsDistributor
  40. 40
    116 registrationsDistributor
  41. 41
    114 registrationsMaker's own entity
  42. 42
    114 registrationsMaker's own entity
  43. 43
    113 registrationsRegulatory representative
  44. 44
    110 registrationsMaker's own entity
  45. 45
    107 registrationsDistributor
  46. 46
    99 registrationsDistributor
  47. 47
    94 registrationsDistributor
  48. 48
    93 registrationsMaker's own entity
  49. 49
    EHC SUPPLYSingapore
    93 registrationsRegulatory representative
  50. 50
    89 registrationsDistributor

Download all 867 company rows as CSV

Company level only: names that are only a person's name are left out.

How many holders also distribute

314 of the 868 holders listed here (36%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.

The others: 327 makers' own import or sales entities, 82 manufacturers and 145 regulatory representatives that hold registrations with no sign in the registries that they supply the market.

Holders that also distribute in Singapore: top 20

  1. 1
    244 registrationsDistributor
  2. 2
    222 registrationsDistributor
  3. 3
    222 registrationsDistributor
  4. 4
    218 registrationsDistributor
  5. 5
    177 registrationsDistributor
  6. 6
    133 registrationsDistributor
  7. 7
    130 registrationsDistributor
  8. 8
    119 registrationsDistributor
  9. 9
    116 registrationsDistributor
  10. 10
    107 registrationsDistributor
  11. 11
    99 registrationsDistributor
  12. 12
    94 registrationsDistributor
  13. 13
    89 registrationsDistributor
  14. 14
    83 registrationsDistributor
  15. 15
    81 registrationsDistributor
  16. 16
    79 registrationsDistributor
  17. 17
    75 registrationsDistributor
  18. 18
    74 registrationsDistributor
  19. 19
    71 registrationsDistributor
  20. 20
    69 registrationsDistributor

See every independent distributor in Singapore on the country page.

Independent holders in Singapore: top 20

Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.

  1. 1
    150 registrationsRegulatory representative
  2. 2
    125 registrationsRegulatory representative
  3. 3
    113 registrationsRegulatory representative
  4. 4
    EHC SUPPLYSingapore
    93 registrationsRegulatory representative
  5. 5
    79 registrationsRegulatory representative
  6. 6
    67 registrationsRegulatory representative
  7. 7
    62 registrationsRegulatory representative
  8. 8
    33 registrationsRegulatory representative
  9. 9
    29 registrationsRegulatory representative
  10. 10
    22 registrationsRegulatory representative
  11. 11
    19 registrationsRegulatory representative
  12. 12
    17 registrationsRegulatory representative
  13. 13
    16 registrationsRegulatory representative
  14. 14
    16 registrationsRegulatory representative
  15. 15
    13 registrationsRegulatory representative
  16. 16
    12 registrationsRegulatory representative
  17. 17
    12 registrationsRegulatory representative
  18. 18
    10 registrationsRegulatory representative
  19. 19
    9 registrationsRegulatory representative
  20. 20
    9 registrationsRegulatory representative

Medical device registration in Singapore with CE or FDA clearance

With CE marking or FDA clearance: Either one opens a shorter reliance route.

HSA abridged and expedited routes for devices approved by a reference agency (FDA, EU notified bodies, Health Canada, TGA, Japan); a local registrant files.

Sources: HSA Singapore, Register Class C medical device via abridged route (reference regulatory agencies). Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.

How to check it yourself in the official register

HSA Singapore Medical Device Register (SMDR), public listing. The advanced search filters by registrant and by product owner.

The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.

What changes if you switch holder

The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.

Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 145 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.

The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.

Next step

All guides

Registration holders in Singapore: questions

Who can be a registration holder in Singapore?

In Singapore the company that registers a device with HSA is its registrant.

Can a distributor hold my registration in Singapore?

In the Index, 314 of the 868 HSA registrants listed for Singapore are also independent distributors. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.

Is there a list of HSA registrants?

Yes. This page lists the top 50 of the 868 HSA registrants the Index holds for Singapore, each linked to its profile, and the CSV carries 867 company rows. The official record is the HSA Singapore Medical Device Register (SMDR), public listing.

How do I check who holds a device registration in Singapore?

Use the HSA Singapore Medical Device Register (SMDR), public listing. The advanced search filters by registrant and by product owner.

Sources

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.