HSA-SMF Partnership Pioneers Integrated Regulatory Support for MedTech Industry to Promote Access into Singapore and Other Markets

From 2 October 2025, the Health Sciences Authority (HSA) and the Singapore Manufacturing Federation Medical Technology Industry Group (SMF MTIG) are pioneering a comprehensive support ecosystem for Singapore's MedTech industry through their strategic partnership, combining the SME Centre@SMF's services with HSA’s Health Products Regulation Group (HPRG) Innovation Office's technical regulatory expertise.

2        This dual-pronged approach transforms the regulatory journey from reactive compliance to proactive guidance, offering early consultations during product development or registration. It also promotes awareness to HSA’s agile frameworks and new initiatives such as the mutual reliance pilot between Medical Device Authority (MDA) of Malaysia and HSA. Signed on 22 August 2025, the Medical Device Regulatory Reliance Programme with Malaysia runs from 1 September 2025 to 28 February 2026, facilitating faster registration processes for Class B, C and D medical devices.

3        HSA has established reliance programmes with Australia, Hong Kong, Philippines, Thailand, and Sri Lanka, which companies can tap on to reduce time-to-market. As of September 2025, more than 500 applications of medical devices have been processed through Thailand and Australia’s reliance on HSA’s approval. The strategic alignment between regulatory excellence (See Annex A for details) and industry support infrastructure positions companies to capitalise on Singapore's growing international regulatory influence while receiving the guidance needed to navigate these accelerated approval processes effectively

4        "Close partnership between regulator and industry association is essential to ensure regulations remain relevant and responsive to the dynamic needs of this rapidly evolving transformative industry. This enables us to co-create forward-looking regulatory frameworks that accelerate breakthrough technologies to market whilst upholding our unwavering commitment to patient safety. This collaborative approach positions Singapore at the forefront of global regulatory excellence and reinforces our role as a trusted gateway for MedTech innovation both in Asia and globally," said Adjunct Professor (Dr) Raymond Chua, CEO of HSA.

Enhanced Support through SME Centre@SMF

5        SMF is happy to partner with HSA’s HPRG Innovation to utilise business advisory services from SME Centre@SMF to provide early regulatory consultation. This enables MedTech companies to receive expert guidance during the critical early stages of product development and regulatory planning, potentially streamlining and expediting their path to market. Specialised professional development programmes (See Annex A for details) will also be rolled out to help MedTech companies navigate the regulatory landscape more effectively and efficiently. HSA experts will serve as speakers and advisors for these programmes, sharing insights on regulatory requirements and best practices to build industry capability and understanding.

6        “We’re excited for this collaboration with HSA to unite Singapore’s MedTech ecosystem. This collaboration provides our companies with a clear pathway to success. We've built an integrated foundation where streamlined regulatory processes, a robust framework for intellectual property protection, and essential trade facilitation services like the Certificate of Origin are all seamlessly linked. This enables firms in Singapore to innovate, scale manufacturing, and secure their assets, giving them a strong launchpad to access global markets.” said Eugene Yoo, Chairman, SMF-MTIG, “We encourage all MedTech companies to join the MTIG industry group to reinforce Singapore’s position as a thriving MedTech hub and leader in the region.”

7        “While clinicians and researchers develop innovative concepts, it is the manufacturing sector that turns these ideas into tangible, life-changing products. Singapore's MedTech success is built on an ecosystem defined by an agile and responsive regulatory framework and strong Intellectual Property (IP) protection. We hope more industry players will work with us in managing the complex regulatory environment for Software as a Medical Device (SaMD) and AI-powered devices, and by creating new approval schemes to boost innovation,” said Dennis Mark, CEO of the Singapore Manufacturing Federation,” said Dennis Mark, CEO of the Singapore Manufacturing Federation.

HSA's HPRG Innovation Office: Driving Regulatory Innovation

8        HSA has established the Health Products Regulation Group (HPRG) Innovation Office bringing together all agile regulatory frameworks and sandbox initiatives under one roof. The office pioneers responsive regulatory approaches that adapt to rapidly evolving technologies whilst maintaining rigorous safety and efficacy standards. Examples of agile frameworks for the MedTech industry includes the Software as a Medical Device (SaMD) Change Management Programme, the Singapore Health Product Access and Regulatory E-System (SHARE), the Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)) and the Centre for Advancing Regulatory Science Research in Next-Generation Therapeutics (ASCENT) (See Annex A for details).

HEALTH SCIENCES AUTHORITY SINGAPORE
SINGAPORE MANUFACTURING FEDERATION
2 OCTOBER 2025 

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