KSurgical
Singapore, Singapore
Singapore repair centre for surgical instruments and flexible and rigid endoscopes, and regional distributor, established in 2000.
Lau Yau Shiong & Co
Singapore, Singapore
Singapore importer, exporter and wholesaler of dental equipment, supplies, instruments and dental materials.
Sunny Dental Medical Supply
Singapore, Singapore
Singapore dental medical supplier of endodontic, prosthodontic and orthodontic products, certified for good distribution practice.
Business types in Singapore
Medical exhibitions in Singapore
Regulation in Singapore
Regulator: Health Sciences Authority (HSA), Medical Devices Cluster
HSA classes devices A-D. Class B-D need product registration; Class A is exempt (notification required). Manufacturers, importers, wholesalers need dealer's licences.
From the sourced HPA / HP(MD)R entry, checked 29 October 2026. General information, not legal advice. Requirements for Singapore · All medical certifications
Frequently asked questions
Can an FDA or CE approval shorten HSA registration in Singapore?
Yes, for Class B to D devices. HSA offers full evaluation where there is no reference approval, and an abridged evaluation where the device has at least one approval from a reference regulator: TGA, an EU notified body, Health Canada, Japan's MHLW or US FDA, for the same labeled use. Expedited routes (Class C and D) and an immediate route (Class B) apply where conditions are met.
One catch: approvals for devices that the reference agency exempted as Class I or II do not qualify as reference evidence. A 510(k)-exempt instrument, for example, cannot use its US status this way. Dossiers use the CSDT format. See the medical certifications page.
What should I know before using a Singapore company as a distributor for Southeast Asia?
A Singapore license or registration covers Singapore only. Neighboring markets have their own systems: Malaysia requires MDA registration with a Malaysian authorized representative and establishment licenses, Indonesia requires a Kemenkes marketing authorization filed by a licensed local distributor, and Thailand requires Thai FDA establishment registration and product listing, notification or licensing by class.
A Singapore partner may coordinate these, but each market still needs a locally licensed entity. The directory currently lists 7 companies in Singapore, all on the Singapore city page; see also the Singapore country page.