In the latest issue of the NEX2US newsletter (May 2025), Singapore’s Health Sciences Authority (HSA) shared several notable regulatory updates and industry engagements relevant to medical device stakeholders. Below is a curated summary focused exclusively on the medical devices section, spotlighting initiatives that could impact both current registrants and manufacturers in the sector.
Change Management Program (CMP) for Software as a Medical Device (SaMD)
HSA has officially rolled out its Change Management Program (CMP), tailored for SaMD, including those powered by Machine Learning (ML). This new optional regulatory pathway, introduced after a public consultation held from August to October 2024, integrates with existing Premarket Product Registration and Change Notification (CN) processes.
The key highlight is the introduction of pre-specified changes, allowing manufacturers to streamline regulatory clearance for anticipated updates, particularly useful for software that evolves rapidly. This is a strategic move to support timely updates while maintaining oversight.
UDI System Expansion: Class D Devices Now Under Mandatory Labelling
As part of Singapore’s progressive Unique Device Identifier (UDI) implementation, Phase 2 has taken effect since 1 November 2024. All Class D general and IVD medical devices must now bear UDI labelling before supply in Singapore. To date, HSA confirms that all existing Class D registrations have submitted UDI information on the Singapore Medical Device Register (SMDR). The next steps? UDI requirements will gradually expand to include Class C and B devices.
Fostering ML-Enabled Device Development: HSA-MFDS Collaboration
To strengthen regulatory clarity for Machine Learning-Enabled Medical Devices (MLMD), HSA and Korea’s MFDS have jointly released clinical trial guiding principles. These aim to address the complex and evolving nature of MLMD assessments and promote safer, more efficient innovation. This joint effort supports regulatory harmonization and helps manufacturers navigate clinical evaluation more effectively for AI-driven technologies.
NextGen MD Initiative Webinar: Accelerating Access for New Tech
On 13 June 2024, HSA hosted a virtual session on its Next Generation Medical Devices (NextGen MD) initiative. The program is designed to simplify the registration process by allowing applicants to leverage existing data from registered devices. With around 370 attendees, the event reflects strong industry interest in regulatory flexibility for next-gen technologies.
Good Submission Practice Workshop: Avoiding Common Pitfalls
Held on 28 August 2024, this workshop drew about 500 participants and zeroed in on common documentation issues in Medical Device submissions. HSA emphasized that high-quality submissions lead to faster reviews and fewer queries, ultimately benefiting applicants. Key takeaway: Clear, complete documentation is more than a checkbox, it’s your fast track to approval.
Official Source: NEX2US Newsletter Issue 11 | May 2025
Published by HSA on 20 May 2025
