In brief
The Health Sciences Authority (HSA) has become the first national regulatory authority globally to achieve the highest World Health Organization (WHO) Maturity Level 4 (ML4) for medical device regulatory systems.
HSA has continually emphasised its desire to set the pace in global regulatory innovation, undertaking partnerships with research institutions to strengthen Singapore’s position as a global thought leader and other national regulatory authorities to strengthen Singapore’s position as a leading biotech hub; and also constantly refreshing its various guidelines to take into account the rapidly evolving developments especially in the healthtech space.
WHO has now recognised HSA’s capabilities and its highest levels of excellence and credibility with regards to its medical device pre- and post-market regulatory functions. HSA can be regarded as a global reference authority that all other regulators worldwide can confidently rely on to protection public health and safety.
In more detail
Following a comprehensive assessment using WHO’s Global Benchmarking Tool Plus for medical devices, HSA has attained ML4, the highest classification in WHO’s system for national regulatory authorities overseeing medical products. Singapore is the first WHO member state to attain this level for medical device regulation.
HSA’s attainment of WHO ML4 for medical devices builds on earlier milestones, including WHO’s recognition of HSA as a Stringent Regulatory Authority for ML4 status for medicines regulatory systems in 2022 and high risk in-vitro diagnostics in 2023.
HSA has committed to continue its excellence and to expand its economic role. HSA intends to set up an industry development function to provide a holistic value proposition to the industry and evolve its regulatory framework:
- HSA will collaborate closely with the Agency for Science, Technology and Research (A*STAR), the Economic Development Board (EDB) and Enterprise Singapore. Key initiatives include supporting translational research and industry-relevant innovation to attract manufacturing, R&D and regional headquarter investments for Singapore.
- HSA will implement a Research, Innovation and Enterprise (RIE) Plan comprising a series of rolling five-year investments, with SGD 37 billion allocated to the latest plan. One of the key areas of investments is human health and potential, where HSA will work alongside universities, academic medical centres, hospitals and A*STAR to strengthen biomedical innovation pipeline.
- HSA will continue partnering with public sector agencies to enhance clinical trial capabilities to grow the number of clinical trials in Singapore.
HSA will continue advancing its regulatory capabilities to embrace emerging technologies, one of the recent examples being the launch of a revised AI in Healthcare Guidelines on 10 March 2026. HSA has also adopted AI technologies to create value for industry partners, such as incorporating the use of AI in its classification tools that the public may utilise.
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