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January 30, 2026
Approximately 5 minutes
Overview of Medical Device Registration in Singapore
Overview of Medical Device Registration in Singapore
1. Regulatory Authority and Scope
The Health Sciences Authority (HSA) regulates medical devices in Singapore under the Health Products Act and the Health Products (Medical Devices) Regulations. Registration is mandatory for all medical devices intended to be imported, manufactured, or supplied in Singapore, except for certain exempted low-risk items. https://www.hsa.gov.sg/medical-devices/registration/overview
2. Risk-Based Classification System
Singapore adopts a four-class risk-based approach aligned with international standards:
- Class A — Lowest risk (e.g., bandages, manual surgical instruments, non-sterile gowns)
- Class B — Low to moderate risk (e.g., hypodermic needles, suction equipment, contact lenses)
- Class C — Moderate to high risk (e.g., ventilators, infusion pumps, diagnostic ultrasound systems)
- Class D — Highest risk (e.g., implantable defibrillators, heart valves, active implantable devices)
Classification is determined using rules similar to those in the ASEAN Medical Device Directive and IMDRF principles. https://www.hsa.gov.sg/medical-devices/registration/overview
3. Registration Pathways
- Class A — Notification only (immediate listing upon submission of basic information)
- Class B — Conformity assessment by Authorized Representative; full technical dossier required
- Class C & D — Full evaluation by HSA, including review of design, clinical evidence, and quality management system
- Prior Approval Route — For devices already approved by reference agencies (e.g., US FDA, EU Notified Body, TGA Australia), abridged evaluation is possible https://www.hsa.gov.sg/medical-devices/registration/overview
4. Key Requirements for Registration
All applicants must appoint a Singapore Authorized Representative (AR) who is responsible for:
- Submission of applications
- Communication with HSA
- Post-market surveillance and vigilance reporting
Required documents typically include:
- Device description and intended use
- Labeling and instructions for use (in English)
- Quality management system certification (ISO 13485)
- Declaration of Conformity
- Free Sale Certificate or equivalent from country of origin
- Technical dossier per class requirements https://www.hsa.gov.sg/medical-devices/registration/overview
5. Timelines and Fees
Timelines vary by class and route:
- Class A Notification: Immediate upon complete submission
- Class B: 60–120 working days
- Class C/D: 120–180 working days or longer for full evaluation
Official fees are payable for each application, with additional charges for priority review or complex products. https://www.hsa.gov.sg/medical-devices/registration/overview
6. Post-Registration Obligations
After approval:
- Maintain vigilance system for adverse event reporting
- Conduct post-market surveillance
- Notify HSA of changes to device or labeling
- Renew registration periodically (validity typically 5 years)
- Comply with labeling, advertising, and distribution controls https://www.hsa.gov.sg/medical-devices/registration/overview
Singapore’s transparent, risk-proportionate registration framework supports timely market access while ensuring high standards of safety and performance for medical devices. https://www.hsa.gov.sg/medical-devices/registration/overview
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