Singapore Medical Device Registration (HSA – Health Sciences Authority)
1. Regulatory Authority & Framework
Singapore regulates medical devices under:
- Health Products Act (HPA)
- Health Products (Medical Devices) Regulations
- Various GN/SMDR guidance documents (GN-10, GN-21, GN-34, etc.)
Regulatory authority:
HSA – Health Sciences Authority, Medical Devices Branch
Registration database: SMDR (Singapore Medical Device Register)
Submission portal: MEDICS (HSA online system)
2. Device Classification (Class A/B/C/D – GHTF/ASEAN-Aligned)
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low | Non-sterile bandages, tongue depressors |
| Class B | Low–Moderate | Infusion sets, suction equipment |
| Class C | Moderate–High | Blood glucose meters, HF surgical units |
| Class D | High | Ventilators, implants, surgical robots |
Classification rules follow IMDRF/GHTF and ASEAN criteria.
3. Registration Pathways
Singapore offers the most flexible pathways in ASEAN, especially for CE/FDA/TGA/MHLW/Korea-approved devices.
3.1 Class A (Non-Sterile) – Listing Only
- No evaluation by HSA
- Only listing required
- Very fast (1–2 weeks)
- Validity: Indefinite
3.2 Class A (Sterile) / Class B / Class C / Class D
There are three possible routes:
Route 1 – Full Evaluation (for devices without prior approvals)
Required when the device does NOT have approvals from HSA’s Reference Regulatory Agencies (RRA):
RRAs include:
- US FDA
- EU Notified Body (under MDR/MDD)
- Health Canada
- TGA Australia
- PMDA/MHLW Japan
- MFDS Korea
Full Evaluation Requirements
- Full CSDT dossier
- ISO 13485
- Safety & performance evidence
- Clinical evaluation (CER)
- Risk management (ISO 14971)
- Electrical safety (IEC 60601) / software lifecycle (IEC 62304)
- Labeling in English
Route 2 – Abridged Evaluation (RRA-Approved Devices)
Applicable if the device is approved in at least one RRA.
HSA reduces technical review burden.
Benefits:
- Less documentation
- Faster review
Route 3 – Immediate Registration Route (IRR)
The fastest route for RRA-approved devices.
Eligibility:
- Device approved by ≥ 2 RRAs
- No safety issues in global markets
- Device’s intended use matches the RRA approvals
Approval time:
- As short as 30 working days
4. Dossier Requirements (CSDT – ASEAN Format)
Singapore uses the ASEAN CSDT structure:
Administrative Documents
- Application form
- Letter of Authorization (LOA) for Local Authorized Representative
- Proof of RRA approvals (if applicable)
- ISO 13485 certificate
- Manufacturer licence/establishment information
Technical Documents
- Device description & intended purpose
- Essential Principles checklist
- Design verification & validation
- Biocompatibility studies
- Electrical safety & EMC (IEC 60601 series)
- Software documentation (IEC 62304 + cybersecurity)
- Sterilization validation
- Clinical evidence (CER)
- Risk analysis (ISO 14971)
- Labeling & IFU (English required)
5. Local Authorized Representative / Registrant
Foreign manufacturers must appoint a Singapore Registrant (local company):
Responsibilities:
- Product registration
- Importer & distributor licensing coordination
- Post-market vigilance reporting
- FSCA/recalls
- SMDR listing maintenance
Singapore allows multiple importers, but each depends on the same Registrant.
6. Fees & Timelines
6.1 HSA Official Fees
- Class A (Listing): SGD 50
- Class B: SGD 1,000–2,000
- Class C: SGD 4,000–6,000
- Class D: SGD 6,000–8,000
6.2 Evaluation Timelines
- Class A (Non-sterile): 1–2 weeks
- Class A (Sterile): 1–2 months
- Class B: 3–6 months (abridged: ~2–3 months)
- Class C: 6–9 months (abridged: ~4–6 months)
- Class D: 9–12 months (abridged: ~6–9 months)
- Immediate Registration (IRR): ~30–60 working days
7. Labeling Requirements
Singapore requires English-language labeling:
- Device name & model
- Manufacturer & Registrant information
- Country of origin
- Lot/serial number
- Expiry/manufacturing date (if applicable)
- Storage conditions
- IFU (can be electronic IFU if compliant)
Advertising rules are strict—HSA approval required for many claims.
8. Import & Post-Market Requirements
Importation
- Importer licence required
- Each shipment must meet Good Distribution Practice for Medical Devices (GDPMDS)
- Customs clearance via TradeNet system
Post-Market Surveillance
- Mandatory adverse event reporting
- FSCA & recall management
- Product change/variation notification
- SMDR maintenance
- Periodic compliance checks by HSA
9. Notes for Your Device Portfolio (Consulting View)
| Device Type | Expected Class | Singapore Requirements |
|---|---|---|
| Soft contact lenses | Class C | CER required; biocompatibility & clinical evidence important |
| Surgical robots / AR/MR platforms (SyngAR™) | Class D | Full CSDT; strong software validation + cybersecurity mandatory |
| High-frequency electrosurgical devices | Class C/D | IEC 60601 essential; usability documentation beneficial |
| Blood glucose meters & strips | Class C | Performance test data (ISO 15197) required |
| Serum preparation device (single-use) | Class B/C | Sterility validation + performance validation |
10. Advantages of the Singapore Market
- Easiest and fastest registration in ASEAN
- Highly transparent regulatory system
- Immediate Registration Route for CE + FDA devices
- No language translation burden (English)
- ASEAN CSDT alignment for easy harmonization with MY/TH/VN/ID