HSA becomes world's first to get WHO's highest recognition for medical devices regulation

Singapore's Health Sciences Authority (HSA) has achieved the highest recognition from the World Health Organisation (WHO) for its medical devices regulatory systems, Health Minister Ong Ye Kung said on Tuesday (March 10).

HSA is the world's first national regulatory authority to reach this classification, called maturity level 4 (ML4), in WHO's benchmarking system for regulatory systems.

According to WHO, the benchmarking framework assesses the maturity and functionality of national regulatory systems against more than 260 indicators including laboratory testing, clinical trials oversight, regulatory inspections and licensing of establishments.

The exercise was conducted last month by a team of international experts along with WHO staff, and included a review of evidence submitted by HSA and technical discussions with teams responsible for regulatory oversight.

Singapore's regulatory system was determined to be operating at an "advanced level of performance", said Minister Ong at the 29th Session of the International Medical Device Regulators Forum being held here at NTUC Centre.

In his opening speech, the minister said HSA can play an economic role by strengthening the Republic's competitiveness in the biomedical industry.

"HSA will strengthen its position as a regional and global reference authority," he stated, referencing how the agency previously achieved WHO's ML4 for medicines and is recognised as a WHO-stringent regulatory authority for high-risk in vitro diagnostic medical devices.

Ong said the credentials establish HSA as a global reference point in health regulation, positioning Singapore as a "key node" in international co-operation.

The nation will be a gateway for market access to other countries and regions, the minister added: "Singapore is no longer just a market of six million people."

The agency will also offer a holistic value proposition to the sector, and evolve its regulatory framework, including for AI.

On Tuesday, the Ministry of Health and HSA also launched the updated AI in Healthcare Guidelines (AIHGle 2.0) to address developments in AI, such as Generative AI.

"The updated guidelines will enable our healthcare institutions to build and implement clinically safe and effective AI solutions. Regulatory sandboxes will help facilitate the evaluation of these AI solutions in real-world healthcare settings," said Ong.

Updates to AIHGle 2.0 include strengthening accountability through clarity of responsibilities for key stakeholders, improving trust via guidance on transparency to facilitate informed decision-making, and updated guidance on AI deployment, such as assessing and mitigating risks. 

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lim.kewei@asiaone.com