Highest WHO Classification Achieved.
HSA has achieved the World Health Organization (WHO) Maturity Level 4 for medical device regulatory systems, the highest classification under WHO's global benchmarking framework. The recognition was announced on 10 March 2026 at the IMDRF 29th session in Singapore.
Comprehensive WHO Audit Validates HSA's Excellence
The recognition followed a comprehensive assessment conducted by WHO using the Global Benchmarking Tool Plus for medical devices (GBT+MD). This assessment involved reviewing regulatory evidence submitted by HSA, engaging in technical discussions with regulatory teams and evaluating regulatory functions across the product life cycle.
Global Reference Authority Status Strengthens Market Pathways
Implications and Significance. WHO designation positions HSA as a global reference authority, potentially increasing regulatory reliance by other jurisdictions. Medical devices approved by HSA may benefit from facilitated or expedited pathways in markets referencing HSA decisions. The recognition reinforces Singapore's role as a regional gateway for medical device market access and confirms robust regulatory controls across the entire product lifecycle, including pre-market review, clinical evaluation and post-market surveillance.
Singapore Positioned as Regional Regulatory Leader
The recognition is intended to strengthen Singapore's position in global medical device regulation as a trusted reference authority for other regulators and supports regulatory convergence and reliance efforts in the region.
Qualtech Consulting Corporation brings 26+ years of experience as a trusted partner to medical device manufacturers. We've successfully guided clients through countless dynamic regulatory and authority platform shifts across diverse international landscapes.
Whether you're a local startup or an international player, we empower your devices to enhance lives.
Connect with us today here to unlock your medical device potential.
References
- HSA Achieves Highest Level Recognition from WHO for Medical Devices Regulatory Systems; Launches Expanded Economic Development Role for Biomedical Sector
- Singapore revises healthcare AI guidelines, attains WHO top rating for medical device regulation
- Singapore sets global first by reaching WHO's highest classification for medical device regulation