HSA Singapore Medical Device Regulations
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The Health Sciences Authority (HSA) oversees the regulations of medical devices sold in Singapore.
Singapore medical device registration framework
The Health Sciences Authority (HSA) regulates devices under the Health Products Act and Health Products (Medical Devices) Regulations. First establish the local risk class and grouping, then select the registration route. A foreign certificate can support reliance; it does not automatically authorize supply in Singapore.
Registration routes and their limits
| Route | When to assess it | Evidence to resolve before filing |
|---|---|---|
| Class A notification/listing | Exempt from product registration under applicable conditions | Correct class, dealer responsibilities and current GN-22 submission requirements |
| Full evaluation | Class B, C or D without qualifying reliance evidence | Complete safety, performance, quality and clinical package |
| Abridged evaluation | Eligible reference approval for the same intended use | Current authorization, matching device/configurations and route-specific dossier |
| Immediate registration | Eligible Class B routes or the narrowly defined Class C medical mobile application route | Exact approvals, marketing history and safety declarations required by that route |
| Expedited evaluation | Eligible Class C or D devices | Required reference authorizations and all additional route conditions |
Use the live revision of GN-15 in HSA's guidance library. Revision 15 took effect on 1 October 2026. Its Malaysian reliance provision concerns Class B, C and D devices registered by MDA after full CAB assessment, with the same intended use. Both the MDA registration certificate and CAB conformity assessment certificate are relevant; the provision excludes specified medicinal-product and differently classified borderline situations. An MDA registration obtained by a different route is not automatically sufficient.
Dossier, local roles and submission
A Singapore registrant manages the product application and its continuing obligations. Manufacturer, importer and wholesaler dealer licensing is a separate activity-based assessment. Confirm who holds each role, the quality-system evidence required for that activity, and access to complaint and distribution records.
Build the CSDT around the proposed Singapore claims: device description and configurations, Essential Principles, risk management, verification and validation, clinical or IVD performance evidence, manufacturing/QMS evidence, English labeling and IFU, and route-specific reference approvals. Use the current SHARE medical device service and submission checklist, rather than legacy portal instructions.
Fees, review clocks and maintenance
Separate application and evaluation charges, dealer licensing and ongoing product retention fees. Consult HSA's current fee schedule for the selected route. Published evaluation targets exclude applicant response time and do not represent a guaranteed end-to-end launch date. Priority review has defined eligibility criteria and is not an automatic benefit of foreign approval.
Before launch, assign responsibility for annual retention, changes, adverse events, field safety corrective actions and distribution traceability. The postmarket guide connects those duties to the approved configuration and local supply chain.
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Frequently asked questions
No. The Class C immediate route is restricted to eligible standalone medical mobile applications meeting the detailed conditions. General Class C devices must be assessed for full, abridged or expedited evaluation as appropriate.
Under GN-15 R15, qualifying MDA registrations after full CAB assessment may support abridged evaluation for Class B, C and D devices. Confirm identical intended use, the required certificates and all exclusions; an MDA certificate alone does not establish eligibility.
No. Registration addresses the device, while dealer licensing addresses manufacturing, import or wholesale activities. Define the local registrant and supply-chain roles and verify the licence and quality-system requirements for each activity.
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