HSA to expand role in accelerating biomedical sector growth: Ong Ye Kung

The authority plans to strengthen its position as a global reference regulator.

The Health Sciences Authority (HSA) will expand its role beyond regulation as part of efforts to grow Singapore’s biomedical sector, according to Health Minister Ong Ye Kung.

The HSA will pursue three key initiatives, Ong said in his speech at the 29th session of the International Medical Device Regulators Forum.

The authority will strengthen its position as a regional and global reference regulator.

“In 2022, HSA was the first international regulator to achieve the World Health Organization (WHO) Maturity Level 4 status and was amongst the first three regulators recognised as a WHO Listed Authority,” Ong said.

Second, the government will coordinate across agencies to support biomedical companies establishing operations in the country.

These include the Agency for Science, Technology and Research to support translational research and innovation, the Singapore Economic Development Board to facilitate manufacturing investment, and HSA to provide regulatory oversight and product registration.

“We will explore opportunities to align companies’ product offerings with Singapore's priority disease areas, such as cardiovascular diseases, diabetes, and metabolic disorders,” the health minister added.

The HSA will also update regulatory frameworks as technologies evolve, as advances in artificial intelligence (AI), genomics, and precision medicine also introduce potential risks and ethical considerations.

As part of this effort, the government has launched AI in Healthcare Guidelines (AIHGle) 2.0, updating the original framework introduced in 2021.

Ong said the revised guidelines address developments in artificial intelligence, including generative AI.

Regulatory sandboxes will also be set up to evaluate AI solutions in real-world healthcare settings, he added.