In brief
On 28 May 2026, Singapore’s Health Sciences Authority (HSA) published details of its zoom webinar on regulatory updates for medical devices and IVDs that was held on 20 May 2026. The webinar included various topics, including regulatory updates on software medical devices, the AI in Healthcare Guidelines 2.0 (AIHGle 2.0), amongst other updates.
In more detail
HSA’s briefing included the following key regulatory updates:
1. GL-04 regulatory guidelines for software medical devices
These guidelines were updated on December 2025. During HSA’s briefing, it highlighted the key revisions to the guidelines, which includes harmonization of definitions; clarity on regulatory requirements for cybersecurity and machine learning; and the new streamlined pathway for software changes under a change management programme.
2. Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0)
The briefing also covered AIHGle 2.0, which was published on 10 March 2026.
One question was raised regarding AIHGle 2.0 on whether developers, during pre-market submissions, need to ensure compliance with AIHGle 2.0 requirements.
HSA confirmed that for pre-market submissions, compliance with AIHGle 2.0 is not an additional or separate regulatory requirement. The regulatory requirements for AI-enabled medical devices remain unchanged since the publication of AIHGle 2.0.
In this regard, AIHGle 2.0 is intended as a set of recommendations and good practices for healthcare AI developers, deployers and users to support patient safety and enhance trust in the use of AI in healthcare. Software medical device developers should continue to refer to GL-04 Regulatory Guidelines for Software Medical Devices, which sets forth detailed regulatory requirements applicable to software and AI-enabled medical devices.
3. Registration support initiative
HSA also expressly recognized that companies are hesitant to submit registration particularly for medical devices supplied at low volumes and low prices, and old and established medical devices with a long history of medical use (legacy medical devices).
To address these challenges and encourage registration of unregistered medical devices brought in for use via special access routes that are essential / life-saving medical devices for rare clinical situations or legacy medical devices with no registered alternatives, HSA will provide registration support through waiver of product registration evaluation fees while ensuring appropriate standards of quality, safety and efficacy for patient health and safety. Only the application fee will be charged.
HSA has provided further detailed criteria, submission details and the supporting documentation required for such registration.
From 1 June 2026 to 31 August 2026, requests may be submitted to participate in the registration support initiative. HSA would thereafter notify qualifying companies of the fee waiver eligibility by 31 October 2026 and companies should submit registration within one year of notification. These dates would also apply to subsequent years for each annual registration support exercise.
4. Other issues raised
HSA had also covered other issues, including its regulatory reliance programme with the Malaysia Medical Device Authority, which would allow medical devices registered in Malaysia to undergo an abridged route in Singapore; and medical devices registered in Singapore to undergo the verification route in Malaysia.
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