Singapore HSA: A Strong International Reference Authority for Medical Devices

By Beena Maniyar and Sreenu Sattu

Background

The 29^th International Medical Device Regulator Forum (IMDRF) Meeting, hosted by the Singapore regulator, the Health Sciences Authority (HSA), was held in Singapore from March 9-13, 2026. 

It brought together global healthcare regulators, industry representatives, and subject‑matter experts to discuss emerging regulatory trends and harmonization efforts. 

Industry joint workshop

Our Emergo team attended the Industry Joint Workshop for the first two days.  

The main focus of the workshop revolved around the recent release of IMDRF: Playbook for Medical Device Regulatory Reliance Programs . The Playbook builds on existing regulatory reliance approaches, provides high-level strategy, practical examples to support implementation and harmonization across jurisdictions.

Our observations from the sessions follow.

Global recognition for HSA

The HSA was awarded the WHO Maturity Level 4 (ML4) for its medical device regulatory system. This represents the highest level of regulatory maturity. 

Singapore is the first country globally to obtain this designation, which represents the HSA ’s regulatory robustness. 

Advancing AI in healthcare: strategy

The HSA has recently launched an AI‑enabled Medical Device Risk Classification Tool (Beta version). 

This practical and useful tool currently supports general medical devices only and offers automated, preliminary risk classification guidance to support manufacturers during early product development. 

Submissions for Software as a Medical Device (SaMD) are expected to increase, and plans are underway to tackle this.

More detailed guidelines will be made available for medical device vs. non‑medical device determinations and providing more clarity on risk classification. An interesting read for AI in Healthcare is here: Emerging-regulatory-policy-issues/

We believe such initiatives show HSA’s direction toward digital transformation of regulatory tools and risk assessment processes.

Evolving regulatory reliance: for broader market access: Singapore–Malaysia regulatory reliance pathway

As we shared previously, this regulatory pathway aims to enhance regulatory convergence and expedite market access. 

Medical devices registered with the Malaysian Medical Device Authority (MDA) under full evaluation may be eligible for an abridged review pathway in Singapore. (And, the converse for HSA-authorized devices and access to the verification route with the MDA.)

Concluding remarks 

Global recognition and regulatory robustness establish the HSA as a gateway for market access in many other countries and regions. Although small, Singapore can be a valuable commercial reference market. The HSA advances the objectives of the IMDRF and remains open to stakeholder feedback regarding the implementation of regulatory reliance programs in the region.

As part of a manufacturer’s global regulatory strategy, we encourage early engagement and discussions with the HSA. Emergo by UL serves as an in-country representative in Singapore and also provides regulatory consulting for market access in Singapore and with the HSA.