Singapore reaches WHO’s highest classification for medical device regulation

12th March 2026

Summary:
Singapore has set a global first by achieving the World Health Organization’s highest classification for medical device regulation, recognising the strength and maturity of its national regulatory system. The classification reflects the capability of the country’s Health Sciences Authority to effectively oversee the safety, quality and performance of medical devices through strong regulatory processes. WHO assessments evaluate regulatory authorities using its Global Benchmarking Tool, which measures performance across functions such as product authorisation, testing, market surveillance and monitoring of adverse events. Achieving the highest maturity level demonstrates that Singapore operates an advanced and continuously improving regulatory system, helping support access to safe and effective medical products and strengthening international confidence in its regulatory oversight.

Link: https://www.who.int/news/item/10-03-2026-singapore-sets-global-first-by-reaching-who-s-highest-classification-for-medical-device-regulation

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