GN-15 — Medical Device Classification and Registration in Singapore
Comprehensive guide to HSA's device registration framework, classification requirements, and regulatory pathways.
Overview
The Health Sciences Authority (HSA) regulates medical devices under the Health Products (Medical Devices) Regulations 2010. Guidance Note 15 (GN-15 Rev 11, March 2024) provides the framework for device registration, including documentation requirements and the available evaluation routes: full, abridged, expedited, and immediate. GN-15 complements GN-13, which contains the official device risk classification rules.
GN-15 focuses on the registration process, including submission content, supporting evidence, and conformity to the Essential Principles of Safety and Performance. It does not create new classification rules; classification must follow GN-13 criteria.
Risk Classification
Devices in Singapore are assigned one of four risk classes (per GN-13):
| Class | Risk Level | Typical Examples |
|---|---|---|
| A | Low | Bandages, gloves |
| B | Low–Moderate | Syringes, ultrasound systems |
| C | Moderate–High | Ventilators, orthopedic implants, diagnostic software |
| D | High | Pacemakers, heart valves, implantable life-support devices |
The assigned class determines the required documentation, regulatory pathway, and the level of scrutiny by HSA. Manufacturers must justify classification in the Device Master File (DMF) and Essential Principles Conformity Checklist (EPCC).
Software and Digital Health Devices
Software as a Medical Device (SaMD) and Clinical Decision Support Software (CDSS) are regulated if intended for diagnosis, treatment, or monitoring. GN-15 directs applicants to provide sufficient evidence of safety, performance, and risk mitigation. Classification depends on the potential impact on patient care and aligns with GN-13 principles.
Combination Products
Devices that incorporate medicinal and device components are classified based on their primary mode of action (PMOA). The regulatory route (device or therapeutic) is determined by PMOA, and supporting documentation must justify classification, safety, and performance.
Registration Process
GN-15 outlines the following key steps for compliance:
Determine registration route
Full, abridged, expedited, or immediate, depending on class and prior approvals.
Prepare submission
Include DMF, EPCC, risk assessments, clinical evidence (if required), and supporting documentation.
Maintain QMS
Systems should align with SS ISO 13485:2016 for design, production, and post-market surveillance.
Post-Market Surveillance (PMS)
Capture field performance, complaints, and adverse events, and update risk files as necessary.
GN-15 provides templates and guidance on the submission format, ensuring that HSA can efficiently assess conformity with Essential Principles.
Practical Considerations
- SaMD and AI developers should ensure technical documentation demonstrates algorithm validation, clinical evaluation, and risk management.
- Combination product manufacturers should engage early with HSA to confirm PMOA and applicable submission pathway.
- Dealers and importers must verify that all devices are registered in the Singapore Medical Device Register (SMDR) before supply.
Key Takeaways
GN-15 Rev 11 clarifies the registration process and reinforces alignment with international risk-based frameworks. Devices must be classified per GN-13, and registration submissions must provide evidence of conformity with Essential Principles. Proactive documentation, QMS alignment, and PMS activities are critical to ensure smooth regulatory approval and continued market access.
References
- • HSA GN-15 Revision 11 (March 2024) – Guidance on Medical Device Product Registration.
- • HSA GN-13 – Risk Classification Rules for General Medical Devices.
- • HSA SaMD/CDSS Guidance – Software as a Medical Device / Clinical Decision Support Software.
- • Health Products (Medical Devices) Regulations 2010.
- • Singapore Medical Device Register (SMDR).
References
- • HSA GN-15 Revision 11 (March 2024) – Guidance on Medical Device Product Registration.
- • HSA GN-13 – Risk Classification Rules for General Medical Devices.
- • HSA SaMD/CDSS Guidance – Software as a Medical Device / Clinical Decision Support Software.
- • Health Products (Medical Devices) Regulations 2010.
- • Singapore Medical Device Register (SMDR).
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