On 20 May 2026 the Singapore Health Sciences Authority (HSA) held an online industry briefing on medical devices, and published the briefing materials on 28 May. It covered updates on software medical devices, artificial intelligence (AI), in vitro diagnostics (IVD), dealer licences, the Special Access Route (SAR) and regulatory reliance with Malaysia. The summary below is based on HSA’s official briefing materials.
1. Updated GL-04 guidelines for software medical devices (including machine learning-enabled medical devices, MLMD)
- Consolidates software life-cycle requirements into a single reference and aligns key terms with International Medical Device Regulators Forum (IMDRF) guidance;
- Adds cybersecurity expectations across pre- and post-market stages, including operating system support and end-of-support planning;
- Clarifies pre-market information requirements for MLMDs, such as model description, datasets and clinical workflow;
- Requires risk management for ML-specific risks such as overfitting, model drift and performance degradation;
- Aligns the MLMD change notification flowchart with GN-21 (change notification guidance).
2. New Change Management Program (CMP)
A new CMP section in GL-04 allows manufacturers to implement software changes pre-agreed with HSA through their own quality management system (QMS), with HSA monitoring post-market, instead of submitting a change notification (and paying a fee) for each change.
3. Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0)
- Published on 10 March 2026, replacing the 2021 version;
- Clarifies accountability across developers, deployers and users, and strengthens transparency and explainability;
- Adds risk-based tools for validation, monitoring, model drift and generative AI, plus a Deployers’ Toolkit;
- Note: AIHGle 2.0 is a set of recommended good practices and not an additional requirement for pre-market submissions. Registration requirements for AI medical devices are unchanged; detailed requirements remain in GL-04.
4. IVD changes (from 2 June 2026)
- COVID-19 IVDs are reclassified from Class D to Class C, with requirements aligned to other Class C infectious disease IVDs;
- The “IVD Cluster” grouping in GN-12-1 is discontinued; specific IHC (immunohistochemistry) and FISH (fluorescence in situ hybridisation) groupings in GN-12-2 are retained and will be expanded, with industry feedback invited until 31 July 2026.
5. Dealer licences: audit reports required (from 1 April 2026)
When applying for or renewing a medical device dealer licence, the latest audit report must be submitted together with the QMS certificate (GDPMDS, MDSAP or ISO 13485).
6. Special Access Route (SAR) registration support initiative (evaluation fee waiver)
- Covers unregistered Class C/D essential or life-saving devices supplied via SAR, and legacy devices with no registered alternative in Singapore;
- Proposals must come from healthcare institutions and be endorsed by the Chairman, Medical Board (public institutions) or the Academy of Medicine, Singapore (private institutions);
- Qualifying devices pay only the S$560 application fee; evaluation fees are waived;
- 2026 window: 1 June to 31 August; HSA will notify qualifying companies by 31 October, and registration must be submitted within one year of notification (by 30 October 2027 for the 2026 cycle); the exercise will run annually;
- There is no committed turnaround time, and SAR supply may continue during evaluation.
7. Regulatory reliance with Malaysia’s MDA
- Class B, C and D devices that have completed full conformity assessment by a CAB (conformity assessment body) recognised by Malaysia’s Medical Device Authority (MDA) and are registered with the MDA can use the abridged evaluation route in Singapore;
- Applicants opt in on the SHARE system by selecting “Regulatory reliance Program: Malaysia Medical Device Authority (MDA)” and submit the MDA registration certificate, the CAB certificate of conformity and GN-15 Annex 5 and Annex 7 documents;
- Conversely, devices registered in Singapore can use the verification route in Malaysia.
Recommendations for companies
- Software/AI products: update cybersecurity, ML dataset and model description, and risk management documentation against the new GL-04, and consider whether a CMP suits future software updates;
- COVID-19 IVDs: confirm registration documents meet Class C requirements;
- Dealers: have the latest QMS audit report ready before renewal;
- Products registered in Malaysia: consider the reliance route to enter Singapore with a shorter evaluation.
Official information: HSA website www.hsa.gov.sg. For support with HSA registration, dealer licences or software/AI medical device compliance, please contact the EVERBIZ medical device compliance team.