In support of digital health product innovation, the Health Sciences Authority (HSA), Singapore, collaborated with the Ministry of Food and Drug Safety (MFDS), Korea, to publish guiding principles for conducting clinical trials of machine learning-enabled medical devices (MLMD). This guideline version is effective from 11 December 2024. Core Guiding Principles

Online medical device transactions and submissions have been conducted via the Medical Device Information and Communication System (MEDICS) with the Health Sciences Authority (HSA), Singapore. On 21 May 2025, an industry briefing session announced the replacement of MEDICS with the Singapore Health Product Access and Regulatory E-System (SHARE). SHARE is

An official observer of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC), the Health Sciences Authority (HSA), Singapore, informs that the official website has been launched at https://www.mdsap.global/. MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that