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March 16, 2025
Approximately 5 minutes
Medical Device Registration in Singapore: HSA's Multi-Route Reliance System
Medical Device Registration in Singapore: HSA's Multi-Route Reliance System
The Health Sciences Authority (HSA) is the regulatory body responsible for medical device registration and licensing in Singapore. Applications are submitted through the SHARE system (Singapore Health Product Access and Regulatory E-System), and approved devices are listed on the Singapore Medical Device Register (SMDR).
License Holder and Compliance Requirements
- Local Registrant: A local entity, known as the Registrant, is mandatory to submit the application and hold the license on behalf of the foreign manufacturer. This entity must also be registered with ACRA.
- Quality System: Must be documented with evidence of quality system conformity, typically an ISO 13485 certificate, or an audit report from the US FDA or Japanese PMDA.
- Post-Market: Registration is valid as long as annual listing fees (Class B: S$39, Class C: S$67, Class D: S$134) are paid and vigilance obligations are met.
- Documentation: Submissions use the ASEAN Common Submission Dossier Template (CSDT) format.
Device Classification and Registration Routes
HSA follows Global Harmonization Task Force (GHTF) guidelines, classifying devices into four risk classes (A-D). Class A devices do not require pre-market registration but must be listed annually. Registration routes for Class B, C, and D devices depend on prior approval in Reference Countries (US, EU, UK, Canada, Australia, Japan).
Registration Pathways, Timelines, and Fees (Effective July 1, 2024)
| Class | Pathway | Reference Country Approval | Review Time | Fee (S$) |
|---|---|---|---|---|
| B | Immediate | 2 | Immediate | S$1,000 |
| B | Abridged | 1 | 100 days | S$2,010 |
| B | Full | None | 160 days | S$3,900 |
| C | Immediate | 2 (SaMD only) | Immediate | S$3,340 |
| C | Expedited | 2 | 120 days | S$3,340 |
| C | Abridged | 1 | 160 days | S$3,900 |
| C | Full | None | 220 days | S$6,250 |
| D | Expedited | 2 | 180 days | S$5,930 |
| D | Abridged | 1 | 220 days | S$6,250 |
| D | Full | None | 310 days | S$12,000 |
Note: The Immediate route applies to Class B and certain Class C Software as a Medical Device (SaMD) with established profiles. The Expedited route requires two reference country approvals and includes a targeted technical review, while the Abridged route leverages the assessment of one reference country.
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