Health Sciences Authority to speed up medical device access

[SINGAPORE] The Health Sciences Authority (HSA) on Thursday (Mar 12) announced deeper pacts with Malaysia and Uzbekistan, which are expected to contribute to the growth of Singapore’s biomedical sector.

This was done on the sidelines of the International Medical Device Regulators Forum, which runs from Mar 9 to 13. HSA is the host as well as the current chair of the forum.

The collaborations will “pave the way for patients, healthcare and industry practitioners in the respective markets to enjoy greater access to medicines, medical devices and other healthcare innovations”, said HSA.

Since Mar 1, medical devices registered with HSA have been able to benefit from a quicker review process for access to the Malaysia market, under the Medical Device Regulatory Reliance Programme.

Similarly, medical devices registered with Malaysia’s Medical Device Authority (MDA) can be reviewed more swiftly by HSA to enter the Singapore market.

Since September 2025, when the programme’s six-month pilot was launched, at least 15 HSA-registered products have been approved by MDA, the Singapore regulatory authority said.

It also signed a pact with Uzbekistan’s Ministry of Health Centre for Pharmaceutical Products Safety to collaborate on pharmaceuticals, medical devices and advanced therapeutics. This covers key areas such as regulatory science, digitalisation, lab testing and post-market surveillance.

Ultimately, the partnership aims to facilitate faster access to health products. As HSA holds the top-tier World Health Organization Maturity Level 4 (ML4) status for medicines, Uzbekistan relies on the Singapore regulator’s medicine approvals.

The two countries’ agencies are now exploring a similar reliance mechanism for medical devices, following HSA’s recent ML4 achievement in that sector.

Singapore will also apply for full membership in the Medical Device Single Audit Program (MDSAP) in the second half of 2026, said HSA, which currently holds official observer status.

MDSAP is jointly managed by the regulatory authorities of Australia, Brazil, Canada, Japan and the US. The programme allows a recognised auditing organisation to conduct a single audit of a medical device manufacturer that satisfies the regulatory requirements of participating regulatory authorities – thereby replacing multiple manufacturing audits and reducing duplication.

HSA said MDSAP membership will enhance its “regulatory oversight of manufacturers while accelerating patients’ access to safer, more effective medical devices across participating jurisdictions”.