Health Sciences Authority to speed up medical device access

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.

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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”.