The national reference gives innovators, investigators and ethics committees an internationally aligned benchmark for device study applications, strengthening Singapore’s position as a trusted location for medtech clinical research.
Singapore, 20 October 2026—As more medical devices move from the laboratory into first use in patients, Singapore has launched a national reference to make clinical investigations more consistent and predictable. The new reference sets out what a well-prepared device study application should contain, including expectations around design control and documentation, helping to clarify and streamline the ethics review process.
Technical Reference (TR) 151:2026 – Clinical Investigation of Medical Devices was developed under the Biomedical and Health Standards Committee (BHSC) of the Singapore Standards Council (SSC), administered by Enterprise Singapore (EnterpriseSG) and supported by the Duke-NUS Centre of Regulatory Excellence – Standards Development Organisation (CoRE-SDO).
Ms Fiona Loke, Director, Medical Technology Office, SingHealth who convened the working group that developed the TR, said:
“We sought international best practices and worked with industry representatives, public and private healthcare providers, and experts with regulatory and ethics committee experience across Singapore to develop a comprehensive, clear and consistent set of guidelines that balance diverse stakeholder interests. Innovators preparing to undergo an ethics review for their medical device study can now prepare their submissions using a common reference, based on their device's risk class and study stage.”
The TR explains how to apply ISO 14155:2026, the international standard for good clinical practice in medical device investigations, when planning and reviewing device studies in Singapore.
It closes a long-standing gap in the healthcare innovation industry—much of the current guidance for clinical trials was developed with medicines in mind and offers limited direction on device-specific aspects. As a result, device study applications vary widely in content and depth, with innovators lacking a common understanding of what ethics committees expect to see.
This lack of standard practices and consistency often leads to repeated rounds of clarification, where the cost falls hardest on start-ups and small and medium-sized enterprises (SMEs), which have limited regulatory resources. TR 151 aims to clarify the level of design control, testing, risk management and documentation that a study team should show at an ethics review, in proportion to the device’s risk class and stage of development. It also gives reviewers a framework for assessing submissions, including first-in-human, early feasibility studies. The guide covers investigational medical devices, meaning devices that are still experimental for their intended use.
Professor John Lim, Executive Director of the Centre of Regulatory Excellence at Duke-NUS Medical School, said:
“TR 151 brings together what regulators, ethics committees, clinicians and industry have learned about conducting device studies well and sets it out in a form that study teams can apply from the earliest stages of planning. This builds trust in the clinical evidence generated in Singapore and helps innovators bring safe, effective devices to patients with greater confidence.”
The benefits extend across the medtech ecosystem. Manufacturers, sponsors and innovators can use the reference to plan the evidence they need and submit more complete and consistent applications, while ethics committees and institutional review boards gain a common framework for assessing them. This supports participant safety and makes review more predictable.
Together, these improvements can strengthen Singapore’s position as a trusted, internationally aligned location for medical device clinical investigations.
Mr Lee Suen Ming, Chair, Biomedical and Health Standards Committee of the Singapore Standards Council, said:
“Singapore’s medtech ecosystem is producing more homegrown devices that must be tested in patients for the first time. TR 151 provides hospitals, ethics committees and companies with common guidance for conducting these investigations. I encourage the community to adopt it, so that we raise the quality and consistency of submissions while safeguarding participant safety.”
Development and availability
TR 151 was developed by a BHSC working group with representatives from public healthcare institutions, ethics committees, industry and regulatory bodies. Both TR 151:2026 and SS ISO 14155:2026 are available for purchase from the Singapore Standards eShop:
TR 151:2026: https://www.singaporestandardseshop.sg/Product/SSPdtDetail/4c19759f-ec22-49e0-a1e3-4aa54f7bffbe