GN-16 and Quality Management in Singapore's Medical Device Framework
Understanding how Quality Management Systems support GN-16 compliance for medical device manufacturers.
Overview
The Health Sciences Authority (HSA) requires all medical devices supplied in Singapore to meet the Essential Principles of Safety and Performance outlined in Guidance Note 16 (GN-16). These principles set the baseline for safety, performance, and risk management across a device's lifecycle.
GN-16 is not a QMS standard. Instead, it defines outcomes that manufacturers must demonstrate through recognised international standards—mainly ISO 13485:2016 for quality management and ISO 14971:2019 for risk management (HSA GN-16 Rev 4, 2023).
National QMS Benchmarks
Singapore adopts SS ISO 13485:2016 as the national QMS benchmark. Licensed manufacturers and dealers must maintain a QMS aligned with this or equivalent certification (e.g. MDSAP).
For distributors and logistics operators, SS 620 GDPMDS applies to ensure proper storage, handling, and traceability of medical devices (HSA GDPMDS Guidelines).
How QMS Supports GN-16 Compliance
HSA expects manufacturers to maintain an effective QMS covering design, production, and post-market activities. A certified QMS provides objective evidence that a device consistently meets GN-16's safety and performance requirements.
Key QMS elements linked to GN-16:
Management Responsibility
Define a quality policy, objectives, and resources; conduct management reviews; maintain leadership commitment (ISO 13485 §5).
Documentation & Records
Maintain document control, traceability, and retention to justify conformity with each Essential Principle.
Human Resources
Establish and record staff competence and training related to regulatory and product requirements.
Infrastructure
Maintain facilities, calibrated equipment, and environmental controls to ensure product integrity.
Design & Development
Apply structured planning, verification, and validation—especially for Class B–D devices—to demonstrate that user and regulatory requirements are met.
Risk Management
Operate a documented process based on ISO 14971 to identify, evaluate, and control risks throughout the device lifecycle (GN-16 §3.2).
Supplier Control
Qualify and monitor suppliers affecting product quality; maintain quality agreements and performance reviews.
CAPA
Capture non-conformances and complaints, perform root-cause analysis, and verify corrective/preventive action effectiveness.
Post-Market Surveillance
Collect and analyse feedback and incident data; update the risk-management file to confirm continued safety and performance (GN-16 §3.4).
Implementation and Transition
GN-16 does not impose a fixed 18-month transition for all manufacturers. Timelines are only specified in individual HSA programmes (e.g. UDI). Manufacturers must maintain ongoing compliance with the current GN-16 revision once effective.
Demonstrating Conformity
Manufacturers show compliance through an Essential Principles Conformity Checklist (EPCC) that maps each principle to supporting documentation—design, risk, supplier, and post-market records (HSA GN-16 Key Updates 2023).
Audit readiness indicators:
Summary
GN-16 defines what must be achieved—safe, effective, and high-performing medical devices. ISO 13485 and ISO 14971 define how to achieve it. Maintaining a certified QMS aligned with these standards is the recognised way to demonstrate GN-16 compliance and ensure continuous market access in Singapore.
References
- • HSA – Guidance Note 16: Essential Principles for Safety and Performance of Medical Devices, Rev 4 (8 Sep 2023).
- • HSA – Dealer Licensing and ISO 13485 Requirements (2021).
- • HSA – GDPMDS Guidelines (SS 620).
- • HSA – EPCC and Device Registration Guidance (2023).
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