Singapore · Health Sciences Authority · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
3 requirements
Application fee
-
Low-risk (Class A) devices, including Class A IVDs and software, do not need product registration. Manufacturers and importers list them through a product notification, and the devices must still meet the essential principles for safety and performance. Dealer licensing, adverse event reporting and other duties still apply. Any low-risk Class A device, such as a wheelchair, tongue depressor or specimen collection tube.
1. Product notification; 2. Listed in the Class A database.
Outcome: Listing in the Class A medical device database.
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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Singapore: 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, 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.