The Health Product Regulatory Conference 2025 was held by HSA in conjunction with SMF MedTech Day on 2 October 2025. Elevating the theme of "Advancing Singapore's Medtech Ecosystem: be connected, collaborative, and future-ready", the conference highlighted the evolving regulatory landscape, examining both present development and anticipated future trends, especially in relation to advancing digital health products.
HSA has since published the presentations from the Medical Device Cluster (MDC), which offered detailed insight into each topic.
Regulating Tomorrow: Approaches for Emerging Trends
The first talk was conducted by Mr. Ong Ming Hao, who outlined the current Singapore's Healthcare Landscape, which is progressing from traditional non-connected medical devices towards software-driven integrated healthcare solutions. Singapore, as a Digital Health Hub, is growing to adopt more digital health technologies with increasing connectivity in healthcare delivery.
Regulatory Challenges of Digital Health Technologies
Adoption of digital health technologies and the shift towards software-driven healthcare solutions bring new key regulatory challenges such as the rapid development, update cycles, and iterations of software medical devices, cybersecurity, as well as validation of AI/Machine learning capabilities.
Change Management and Product Lifecycle Approach
HSA has established a Regulatory Framework and Approaches to face the abovementioned challenges, such as implementing Regulatory Controls and a Risk-Based Approach. Additionally, HSA also adopts a product lifecycle approach as well as has introduced the Change Management Program (CMP) for Software as a Medical Device (SaMD) to accommodate the rapid development for this specific product type while also ensuring effectiveness and safety through conformity to standards.
Future Trends and HSA's Strategic Directions
In the future, HSA also is considering the emerging trends in the industry such as Advanced Artificial Intelligence/Machine Learning applications implementing autonomous diagnostic systems and analytics for patient outcomes, Real-World Evidence and Performance Monitoring, as well as Generative AI and Genetic AI, which can generate recommendations and contribute to clinical decision making.
HSA's approach moving forward is to: a) Strengthen international collaboration and harmonization, b) Develop adaptive regulatory frameworks for emerging technologies, and c) Support innovation through regulatory science, while still maintaining the fundamental principles such as prioritizing patient safety and product effectiveness, a risk-based regulatory approach, and evidence-based decision-making.
Regulatory Roadmap: Key Initiatives Explained
During the second shared session, Ms. Agnes Goh explained HSA's Key Initiatives to support innovation and facilitate device approvals across the product lifecycle while maintaining high safety standards.
Pre-Market Consultation and Priority Review
Prior to regulatory submission, HSA offers the Pre-market Consultation Scheme, which supports consultations during product development as well as pre-submission, providing early guidance on regulatory alignment. During regulatory submission, HSA provides the Priority Review Scheme, which accelerates evaluation for breakthrough technologies, thus facilitating timely access for devices that address unmet clinical needs.
NextGen MD Initiative and Change Management Program
HSA also previously introduced the NextGen MD Initiative, which supports iterative device development by streamlining evaluation for next-generation devices that share common characteristics and validation data.
Ms. Agnes Goh also explained further on the previously mentioned Change Management Program (CMP) for SaMD. This program can be integrated with product registration or change notification for products that undergo numerous and planned changes. The CMP enables timely implementation of pre-specified changes while maintaining safety standards. Upon approval, the changes can be implemented without individual change applications; however, manufacturers need to submit an annual declaration of the implemented pre-specified changes.
Launch of SHARE System and International Recognition
Concluding the session, Ms. Agnes Goh also introduced the recently launched SHARE system, which replaced MEDICS as HSA's unified and integrated transformative digital platform, as well as updated the audience on Singapore's International Recognition as a Reference Authority in Thailand, Hong Kong, Philippines, Australia, WHO, as well as the newly launched pilot reliance program with Malaysia.
Submission Excellence: Keys to Medical Device Approval
During the last session, Mr. Koh Kah Leng shared HSA's advice on the submission standard for medical device approval. HSA shared the importance of good submission practice and pre-submission planning and strategy. HSA also shared the keys to pre-submission success in Singapore by initially understanding the device and applicable regulatory pathway, which includes the correct classification system and submission route. During submission, documentation excellence is important, such as paying attention to the submission format, technical documentation requirements, as well as HSA-specific requirements. Additionally, early engagement with HSA through pre-submission consultation is also welcomed, especially for new players.
During this section, Mr. Koh Kah Leng also shared common submission pitfalls and best practices expected by HSA.
Unlock Your Medical Device Potential with HSA Expertise
Singapore HSA is an established regulatory agency that is known to be continuously upgrading to cater to fast-developing trends of medical devices. HSA constantly works together with international agencies, stakeholders, and industry players to create a balanced regulatory environment that enables innovation and clinical solutions but at the same time gatekeeps and ensures the device's safety and effectiveness.
HSA approval streamlines the registration process in other key markets, including Malaysia, Thailand, Philippines, Hong Kong, and Australia, as well as making the device eligible for an abridged prequalification assessment by WHO for high-risk IVD medical devices.
Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 25 years. Whether you're a local startup or an international player, we empower your devices to enhance lives.
Connect with us today here to discuss your HSA submission strategy and unlock your medical device potential.
References
- Health Products Regulatory Conference 2025 in conjunction with SMF MedTech Day
- First presentation slides: Regulating Tomorrow: Approaches for Emerging Trends
- Second presentation slides: Regulatory Roadmap: Key Initiatives Explained
- Third presentation slides: Submission Excellence: Keys to Medical Device Approval