HSA · South & Southeast AsiaEvery Singapore dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Search official HSA device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official HSA regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current HSA application, review, and renewal fees.
Estimate the likely HSA pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent HSA policy, guidance, and compliance updates.
Describe your device and get a preliminary HSA risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Singapore requirements.
Describe a device and find comparable products in the HSA registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Common questions about changing a registered medical device in Singapore. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 41 official sources · latest verification 2026-10-21
HSA registration fees in SGD · reviewed 2026-08-25
Health Sciences Authority (HSA) review clocks and planning ranges · 4-class (A, B, C, D) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class A(Notification) Class A is exempt from product registration Manufacturers and importers must still submit a Class A product notification in SHARE | Immediate | Immediate | Verified |
| Class B(IBR/Expedited/Full Route) Four Class B routes, and which one applies is decided by how many reference approvals the device already holds rather than by choice: Immediate Class B Registration is granted on submission, abridged takes 100 working days, full takes 160, and full under the Priority Review Scheme takes 104 IBR needs either one reference approval plus three years of marketing in that jurisdiction, or two reference approvals, and in both cases no global safety issue and no prior rejection or withdrawal. A standalone medical mobile application qualifies for an immediate route on one reference approval with no marketing history Abridged needs at least one reference approval; a device with none must go full route HSA turnaround times exclude applicant stop-clock time | 0-160 working days | 3-9 months | Verified |
| Class C(IBR/Expedited/Full Route) Five Class C routes: an immediate route confined to standalone medical mobile applications, expedited (ECR) at 120 working days, abridged at 160, full at 220, and full under the Priority Review Scheme at 143 ECR-1 needs one reference approval plus three years of marketing there; ECR-2 needs two reference approvals. Both require no prior rejection or withdrawal by HSA or a reference agency Hip, knee and shoulder joint replacement non-bioactive implants are barred from ECR and must go full or abridged HSA turnaround times exclude applicant stop-clock time | 0-220 working days | 6-12 months | Verified |
| Class D(IBR/Expedited/Full Route) Four Class D routes: expedited (EDR) at 180 working days, abridged at 220, full at 310, and full under the Priority Review Scheme at 202. There is no immediate route at Class D EDR needs two reference approvals and no prior rejection or withdrawal. Active implantables, devices contacting the central circulatory or central nervous system, bioactive joint replacements, devices with a registrable drug in a secondary role, and HIV or donor-compatibility IVD assays are barred from EDR A Class D device with a registrable drug in a secondary role has only abridged at 220 and full at 310, and is excluded from the Priority Review Scheme HSA turnaround times exclude applicant stop-clock time | 180-310 working days | 9-18 months | Verified |
Newest official HSA headlines from the daily-refreshed feed — every row links directly to the authority publication.
SingaporeAug 28HSHealth Sciences AuthorityHSA Announces Registration Support Initiative for Unregistered Medical DevicesSingaporeAug 14HSHealth Sciences AuthorityHSA Summary of Responses on Medical Device Cybersecurity Best Practices GuideSingaporeJul 17HSHealth Sciences AuthorityRecall of BD ChloraPrep 1 mL Applicator - Clear (17 July 2026)SingaporeSep 03, 25HSHealth Sciences AuthorityArchived Regulatory GuidancesSingaporeOfficial HSA rules and guidance · 71 of 71 documents linked to official sources
Computed from 20,860 official HSA registration records · data as of 2026-08-21
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Connect the HSA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against HSA administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to HSA evidence, notification, timing, and implementation questions.
Assess a current HSA update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Singapore (HSA).
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