Singapore HSA Signs SFDA and AMA MOUs; NPRA Medicines Reliance Pilot

Singapore's Health Sciences Authority (HSA) has reported new and expanded regulatory collaborations with Saudi Arabia, the African Medicines Agency, Malaysia and the United Kingdom. HSA says the initiatives aim to "reduce duplicated regulatory work". The initiatives also aim to widen the opportunities for regulators in African countries, Malaysia and Saudi Arabia to reference HSA's work. The collaborations were announced between 14 and 16 September 2026, alongside the 30th International Medical Device Regulators Forum (IMDRF) meeting and the Drug Information Association (DIA) Singapore Annual Meeting 2026. HSA published its press release on 17 September 2026.

The announcement covers:

• two memoranda of understanding (MOUs);
• a medicines reliance pilot;
• continued work with the UK;
• HSA's IMDRF chair deliverables.

It does not change HSA's own registration requirements for medical devices. It also does not announce a reliance route that device manufacturers can use in Saudi Arabia or Africa. In Malaysia, device reliance on HSA runs through a separate, existing programme of the country's Medical Device Authority, described below.

What HSA announced

HSA has not published either MOU. The release does not say whether medical devices are within the scope of the SFDA or AMA agreements.

IMDRF deliverables under HSA's 2026 chairmanship

HSA chaired IMDRF in 2026 and lists four deliverables:

• a Reliance Playbook to help regulators build sustainable reliance frameworks;
• an Artificial Intelligence and Machine Learning Technical Framework to support harmonized oversight of AI-enabled medical devices;
• a new Cybersecurity Working Group to develop guidance on cybersecurity-by-design and testing;
• further stakeholder training on Unique Device Identification, conformity assessment and reliance.

At the IMDRF Stakeholder Forum, HSA also presented a large language model (LLM) tool developed with GovTech Singapore. The tool maps medical device adverse event information to IMDRF coding frameworks. HSA expects it to save about 300 officer-hours a year in coding review and validation. The IMDRF chair passes to Brazil's ANVISA from 2027.

What this means for device manufacturers

Pure Global analysis:

• Singapore: nothing in the release changes how devices are registered with HSA.
• Saudi Arabia and Africa: HSA describes neither MOU as creating a reliance route, and HSA has not published their texts. Both speak of exploring facilitative pathways or the use of HSA's approvals as references. Plan for SFDA's current requirements and for each African national regulator's own requirements. Treat an HSA approval as supporting evidence only where that regulator already accepts it.
• Malaysia: the NPRA pilot covers medicines only. Device reliance in Malaysia runs through a separate, existing programme of the Medical Device Authority (MDA), which, since 1 March 2026, accepts Class B, C and D devices registered in Singapore's Medical Device Register through its verification route. Pure Global covered it in Malaysia MDA–HSA Regulatory Reliance 2026.
• AI and cybersecurity: the release does not link the AI/ML Technical Framework or say whether it is final. Earlier in 2026, IMDRF's AI/ML-enabled Working Group ran a public consultation on a proposed Technical Framework for Artificial Intelligence Life Cycle Management (N93). HSA does not confirm that this is the same document. IMDRF documents are not requirements in themselves until a regulator adopts them.
• UK: the Regulatory Innovation Corridor itself is not new. See our report on the Corridor's December 2025 launch.

See Pure Global's Singapore market page and Saudi Arabia market page for current registration routes.