Singapore · Health Sciences Authority · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
2 requirements
Application fee
SGD 17,500
Fee list updated 26 March 2026
An opt-in scheme for Class B, C and D devices on the full route. Review targets are 35 percent shorter than the standard full route: 104 working days for Class B, 143 for Class C and 202 for Class D. Route 1 is for devices in six focus areas that meet an unmet clinical need. Route 2 is open to other full-route devices at a higher fee. Devices with a registrable medicinal product are excluded. A new device with no reference approval whose maker wants a shorter review.
The evaluation fee, class d, full route with priority review scheme route 2 is SGD 17,500 for Fee list updated 26 March 2026.
1. Opt in when filing a full-route application; 2. Priority evaluation, Class B (104 days); 3. Priority evaluation, Class C (143 days); 4. Priority evaluation, Class D (202 days); 5. Decision and listing.
Outcome: Listing on the Singapore Medical Device Register.
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 202 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class D, full route with Priority Review Scheme Route 2Application · Fee list updated 26 March 2026 | SGD 17,500 |
| Evaluation fee, Class D, full route with Priority Review Scheme Route 1Application · Fee list updated 26 March 2026 | SGD 13,600 |
| Evaluation fee, Class C, full route with Priority Review Scheme Route 2Application · Fee list updated 26 March 2026 | SGD 9,000 |
| Evaluation fee, Class C, full route with Priority Review Scheme Route 1 |
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, Class D device registration, expedited evaluation, Device with a registrable medicine (Class D). See all routes on the or explore them in the .
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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| SGD 7,000 |
| Evaluation fee, Class B, full route with Priority Review Scheme Route 2Application · Fee list updated 26 March 2026 | SGD 5,660 |
| Evaluation fee, Class B, full route with Priority Review Scheme Route 1Application · Fee list updated 26 March 2026 | SGD 4,420 |