Singapore standardizes clinical investigations of medical devices

Singapore has introduced a national technical reference intended to make clinical investigations of investigational medical devices more consistent and predictable. Technical Reference 151:2026, titled “Clinical Investigation of Medical Devices,” sets expectations for study applications, including design control, testing, risk management and documentation. It also gives ethics committees and institutional review boards a common framework for evaluating submissions, including applications for first-in-human and early feasibility studies.

The reference was developed by a working group under the Biomedical and Health Standards Committee of the Singapore Standards Council. Enterprise Singapore administers the council, while the Duke-NUS Centre of Regulatory Excellence–Standards Development Organisation supported the work. The group included representatives from public healthcare institutions, ethics committees, industry and regulatory bodies. TR 151 explains how ISO 14155:2026, the international standard for good clinical practice in medical device investigations, should be applied when planning and reviewing device studies in Singapore.

Singapore’s existing clinical-trial guidance was largely designed with medicines in mind and offered limited direction on device-specific considerations, according to the announcement. As a result, applications for medical device studies could vary widely in content and depth, leaving innovators without a shared understanding of what ethics committees expected. Inconsistent applications could trigger repeated requests for clarification, imposing particular burdens on start-ups and small and medium-sized enterprises with limited regulatory resources.

TR 151 seeks to address that variability by linking the evidence expected at ethics review to two features of an investigation: the device’s risk class and its stage of development. The stated aim is not to impose identical requirements on every study, but to establish a proportional approach. Study teams can use the reference while planning their evidence, while sponsors and manufacturers can prepare more complete applications. Reviewers gain an internationally informed framework against which to assess submissions.

Fiona Loke, Director of the Medical Technology Office at SingHealth and the working group convener, said the participants sought international best practices and drew on industry, public and private healthcare providers, and experts in regulation and ethics review. “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,” she said.

Professor John Lim, Executive Director of the Centre of Regulatory Excellence at Duke-NUS Medical School, said the reference consolidates what regulators, ethics committees, clinicians and industry had learned about conducting device studies well. He said TR 151 is applicable from the earliest planning stages and is intended to support trust in clinical evidence generated in Singapore and help innovators bring safe, effective devices to patients with greater confidence.

Lee Suen Ming, Chair of the Biomedical and Health Standards Committee, encouraged the healthcare community to adopt the reference. “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,” he said. He said broader adoption could improve the quality and consistency of submissions while safeguarding participant safety.

The initiative is aimed specifically at investigational medical devices, defined in the announcement as devices that remain experimental for their intended use. It is a procedural standard for preparing and reviewing clinical investigations rather than evidence that any particular device is safe or effective, and the announcement does not report results from patient studies. Its anticipated effects are more predictable ethics review, clearer planning for developers and sponsors, and a more consistent basis for assessing submissions. Both TR 151:2026 and the Singapore adoption of ISO 14155:2026 were made available for purchase through the Singapore Standards eShop.

Subject of Research: A national technical reference for clinical investigations of investigational medical devices in Singapore

Article Title: Singapore launches national reference to guide clinical investigations of medical devices

Article References: Singapore launches national reference to guide clinical investigations of medical devices. Original publication (Bibliographic details unavailable.)

Image Credits: AI Generated

DOI: Not provided

Keywords: medical devices, clinical investigations, ethics review, regulatory standards, ISO 14155, Singapore, risk management, research ethics, healthcare innovation, launches, national, reference