Singapore · Health Sciences Authority · Medical devices
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
SGD 5,930
Fee list updated 26 March 2026
A faster reliance route for Class D devices with approvals from at least two independent reference regulators for the same labeled use. Active implants, some other implants, joint replacements, devices with a registrable drug and high-risk IVDs for HIV or donor testing are excluded. The target is 180 working days from receipt of the application, without stop-clock time. A Class D device with two independent reference approvals that is not on the excluded list.
The official review target is 180 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 d, expedited route is SGD 5,930 for Fee list updated 26 March 2026.
1. Online application; 2. Screening; 3. Evaluation (180 days); 4. Input request (clock stopped); 5. Decision and listing.
Yes. It relies on approvals from Australia, Canada, European Union, Japan, United States (shorter review, shorter review, shorter review, shorter review, shorter review).
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 180 days end to end with the official step targets. Targets, not actual times.
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. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class D, expedited routeApplication · Fee list updated 26 March 2026 | SGD 5,930 |
Other routes in Singapore: Class A device product notification, Class B device registration, full evaluation, 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, 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 (25 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.