• 2026-10-27 05:15:40

Singapore's Health Sciences Authority (HSA) has introduced the submission window for the inaugural year of the Registration Support Initiative for unregistered medical device previously have been accessed through Special Access Routes (SAR) to 31 December 2026. This provides medical and dental practitioners and other stakeholders with additional time to prepare submissions, engage relevant parties and obtain the necessary endorsements. From 2027 onwards, the Initiative will follow a standard annual submission cycle from 1 October to 31 December.

• 2026-10-27 04:39:09

Singapore's Health Sciences Authority (HSA) has published the finalised GL-10 R1 Best Practices Guide on Medical Device Cybersecurity following a public consultation conducted from 10 March to 13 May 2025. The guide provides best practice recommendations and considerations for managing cybersecurity risks associated with connected medical devices throughout the Total Product Life Cycle (TPLC). HSA also published a summary of responses to stakeholder feedback received during the consultation.

• 2026-09-21 03:51:16

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

• 2026-09-21 03:40:18

Singapore's Health Sciences Authority (HSA) has enhanced its Change Notification (CN) process for registered medical devices. With immediate effect, up to two CN applications may now be processed concurrently for the same medical device listing, providing greater flexibility for stakeholders in managing regulatory changes and facilitating more timely implementation of device updates.

• 2026-08-25 08:32:41

Singapore's Health Sciences Authority (HSA) has extended the compliance date for Phase 3 implementation of Unique Device Identification (UDI) requirements from 1 November 2026 to 31 December 2026. Class C General medical devices and in vitro diagnostic (IVD) medical devices must therefore carry UDI labelling prior to import and supply in Singapore from 1 January 2027.

• 2026-07-27 03:54:16

HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.

• 2026-06-26 06:09:06

On 20 May 2026, HSA held a virtual industry briefing to present regulatory updates and support initiatives for medical devices and in vitro diagnostics (IVDs). The session covered revised guidance for software medical devices, updated Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0), audit reporting requirements, regulatory reliance with Malaysia's Medical Device Authority (MDA), reclassification of COVID‑19 IVDs, restructuring of IVD cluster grouping and a registration support initiative for unregistered devices.

• 2026-04-23 09:11:50

Singapore's Health Sciences Authority (HSA) has achieved the World Health Organization (WHO) Maturity Level 4 for medical device regulatory systems, the highest classification under WHO's global benchmarking framework. The recognition, announced on 10 March 2026 during the International Medical Device Regulators Forum (IMDRF) 29th session in Singapore, strengthens Singapore's position in global medical device regulation as a trusted reference authority for other regulators.

• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.