Singapore · Health Sciences Authority · Medical devices
Review target
0 working days
performance goal
Legal time limit
-
Not published
Steps
3
8 requirements
Application fee
SGD 1,000
Fee list updated 26 March 2026
A Class B device is listed on the register as soon as the application is filed and paid, if it has strong reference approvals and a clean safety record. Either one independent reference approval with three years of marketing there, or two independent reference approvals, is needed. Standalone medical mobile apps need one approval. The agency checks the documents after listing and cancels the registration without refund if the device did not qualify. A Class B device, IVD or standalone mobile app with qualifying approvals from Health Canada, Japan MHLW, the US FDA, or the TGA or an EU notified body.
The official review target is 0 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, immediate route is SGD 1,000 for Fee list updated 26 March 2026.
1. Online application and payment; 2. Immediate listing (0 days); 3. Document check after listing.
Yes. It relies on approvals from Australia, Canada, European Union, Japan, United States (recognition, recognition, recognition, recognition, recognition).
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. Listed immediately on submission and payment; documents are checked afterwards. | 0 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class B, immediate routeApplication · Fee list updated 26 March 2026 | SGD 1,000 |
Other routes in Singapore: Class A device product notification, Class B device registration, full evaluation, Class B device registration, abridged evaluation, 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.