Singapore · Health Sciences Authority · Medical devices
Review target
160 working days
performance goal
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
SGD 3,900
Fee list updated 26 March 2026
For a moderately low-risk (Class B) device with no approval from any of the agency's reference regulators. The agency reviews a full ASEAN CSDT dossier, including full preclinical reports and a clinical evaluation report. The target is 160 working days from receipt of the application, without stop-clock time. A Class B device, IVD or software that has not been approved by the TGA, Health Canada, Japan MHLW, the US FDA or an EU notified body.
The official review target is 160 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation fee, class b, full route is SGD 3,900 for Fee list updated 26 March 2026.
1. Online application; 2. Screening; 3. Evaluation (160 days); 4. Input request (clock stopped); 5. Decision and listing.
Outcome: Listing on the Singapore Medical Device Register. A yearly retention fee keeps the listing.
Legal basis: Health Products Act 2007; Health Products (Medical Devices) Regulations 2010
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 160 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Official target counted from receipt of the application, without stop-clock time. Not an actual review time. | 160 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class B, full routeApplication · Fee list updated 26 March 2026 | SGD 3,900 |
Other routes in Singapore: Class A device product notification, Class B device registration, abridged evaluation, Class B device immediate registration, Class C device registration, full evaluation, Class C device registration, abridged evaluation, Class C device registration, expedited evaluation, Class C immediate registration for standalone mobile apps, Class D device registration, full evaluation, Class D device registration, abridged evaluation, Class D device registration, expedited evaluation, Priority Review Scheme for devices, Device with a registrable medicine (Class D). See all routes on the Singapore page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.