Singapore · Health Sciences Authority · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
3 requirements
Application fee
SGD 75,600
Fee list updated 26 March 2026
A device that contains a medicine in a supporting role, such as a drug-eluting stent, is regulated as a device when its main action is physical. Such devices are always Class D and are reviewed jointly by the device and medicines teams. The abridged route (target 220 working days) needs a reference device approval and approval of the drug part by a competent drug regulator. Otherwise the full route applies (target 310 working days). A combination product whose primary mode of action is that of a device.
The evaluation fee, class d device with registrable drug, full route is SGD 75,600 for Fee list updated 26 March 2026.
1. Online application; 2. Joint evaluation, abridged route (220 days); 3. Joint evaluation, full route (310 days); 4. Decision and listing.
Outcome: Listing on the Singapore Medical Device Register as a Class D device.
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 310 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, Class D device with registrable drug, full routeApplication · Fee list updated 26 March 2026 | SGD 75,600 |
| Evaluation fee, Class D device with registrable drug, abridged routeApplication · Fee list updated 26 March 2026 | SGD 10,600 |
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, Priority Review Scheme for devices. 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.