Medical Device Regulation in Singapore
Singapore regulates medical devices through the Health Sciences Authority (HSA) under the Health Products Act. The regulatory framework establishes a risk-based approach to device registration, aligned with international best practices and IMDRF guidelines. Singapore is recognized as a stringent regulatory authority and serves as a key gateway to the Southeast Asian medical device market.
Recent Regulatory Updates
Showing the latest 3 updates. Sign up to see more
New standardized AER terminology with codes.
HSA expands reliance programs with Malaysia and MDSAP
HSA approves 23 therapeutic products in Jan 2026
Sources Tracked by Qalico
Qalico continuously monitors 47 references across guidelines, regulations, and standards for Singapore.
Guidelines
Device Classification
Singapore uses a four-tier risk-based classification system aligned with GHTF/IMDRF rules. Class A covers low-risk devices such as tongue depressors and non-sterile gloves. Class B covers low-moderate risk devices such as hypodermic needles and powered wheelchairs. Class C covers moderate-high risk devices such as orthopedic implants and ventilators. Class D covers the highest-risk devices such as pacemakers and drug-eluting stents.
Official classification guidance →Official Guidance Documents
Official guidance on the medical device registration process in Singapore, including submission requirements and evaluation pathways.
Guidance on the ABCD risk-based classification framework used in Singapore.
Information on adverse event reporting and field safety corrective action requirements.
Standards & Key Principles
Applicable Standards
Key Principles
- All medical devices (Class B, C, D) must be registered with HSA before being supplied in Singapore.
- Class A devices are exempt from registration but subject to general safety requirements and dealer licensing.
- A Singapore-based Registrant is required for all device registrations.
- HSA offers expedited review pathways for devices approved by recognized reference regulatory agencies (e.g., FDA, CE, TGA, Health Canada).
- Dealers (importers, wholesalers, manufacturers) require a valid dealer's license from HSA.
- IMDRF-aligned classification and regulatory principles are applied.
Pre-Market Requirements
Class B, C, and D devices must be registered with HSA through the PRISM portal. Three evaluation routes are available: Immediate (Class B with reference approval), Abridged (leveraging reference agency approvals), and Full (independent evaluation).
All importers, wholesalers, and local manufacturers of medical devices must hold a valid dealer's license issued by HSA.
Manufacturers must provide evidence of conformity including ISO 13485 certification, product testing, and clinical evidence proportionate to device risk.
A Singapore-registered company must act as the registrant for all device registration applications, responsible for regulatory obligations.
Post-Market Requirements
Mandatory reporting of adverse events to HSA, including death or serious deterioration in health, within defined timeframes (immediate for death, 10 days for serious injury).
Registrants must report all field safety corrective actions (recalls, advisories) to HSA and coordinate corrective measures in Singapore.
Registrants must maintain PMS systems and may be required to submit periodic safety reports to HSA.
Device registrations are subject to ongoing compliance. HSA may conduct post-market reviews and request updated documentation.
International Recognition & Reliance
Singapore (HSA) is a founding member of the International Medical Device Regulators Forum and actively contributes to international regulatory harmonization.
Singapore participates in the ASEAN Medical Device Directive harmonization initiative.