Singapore · Health Sciences Authority · Medical devices
Review target
120 working days
performance goal
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
SGD 3,340
Fee list updated 26 March 2026
A faster reliance route for Class C devices. ECR-1 needs one independent reference approval, three years of marketing there and a clean safety record. ECR-2 needs two independent reference approvals. Non-bioactive hip, knee and shoulder joint replacements are excluded. The target is 120 working days from receipt of the application, without stop-clock time. A Class C device with strong approvals from Health Canada, Japan MHLW, the US FDA, or the TGA or an EU notified body.
The official review target is 120 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 c, expedited route is SGD 3,340 for Fee list updated 26 March 2026.
1. Online application; 2. Screening; 3. Evaluation (120 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 120 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. | 120 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class C, expedited routeApplication · Fee list updated 26 March 2026 | SGD 3,340 |
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 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 (25 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.