Singapore, Oct. 23 -- 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.

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)...