Singapore achieves the highest WHO Maturity Level for medical device regulation
Published: 23 Mar 2026
Author: Precedence Research
The World Health Organisation (WHO) announced that Singapore’s Health Sciences Authority (HSA) has achieved the highest level of regulatory performance for medical devices under WHO’s global benchmarking framework.
Singapore is the first WHO Member State to attain this level for medical device regulation. This designation helps the Singapore regulatory system operate at an advanced level of performance with mechanisms for continuous improvement, and consistently ensures the safety, quality, and performance of medical devices throughout their life cycle, from market authorisation and clinical evaluation to post-market surveillance.
WHO Assistant Director-General for Health Systems, Access and Data, Dr. Yukiko Nakatani, said Effective regulation is essential to ensure that health products, including medical devices, reaching patients are safe, effective, and of assured quality. Singapore is a major global hub for medical technology innovation, with around 200 manufacturers producing a wide range of devices, from in vitro diagnostics to software as a medical device.
According to Towards Healthcare, the Refurbished Medical Equipment Market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 23.76 billion in 2026 to approximately USD 62.53 billion by 2035, representing a compound annual growth rate (CAGR) of 11.35% from 2026 to 2035. Singapore's achievement reflects an exceptional commitment to regulatory excellence and demonstrates how sustained investment in regulatory capacity can protect populations, support innovation, and strengthen trust in medical technologies.
Benchmarking Assessment
Chief Executive Officer, Health Sciences Authority, Singapore, Adjunct Professor (Dr) Raymond Chua, said It is a great honour for Singapore’s Health Sciences Authority to be recognised at the highest WHO Maturity Level (ML4) classification for medical device regulation. HSA will continue to collaborate closely with WHO and partners to share experience and support regulatory capacity building across the Region, at the same time work with regulators to establish HSA as a global reference point that they can confidently rely on for the evaluation of their products".
GBT+MD is an extension of WHO’s Global Benchmarking Tool (GBT), designed to assess and strengthen national regulatory systems for medical devices. While based on regulatory principles common to other medical products, such as medicines and vaccines, the GBT+MD addresses the specific challenges associated with regulating medical technologies.
A recent report by Towards Healthcare highlights that the Refurbished Medical Equipment Market is experiencing a regulatory authority that is positioned to help advance global regulatory alignment for emerging technologies, such as digital health solutions, artificial intelligence, and personalised medical devices