The Department of Health (DOH) has issued Department Circular No. 2025-0240, temporarily suspending the implementation of Administrative Order (AO) No. 2024-0016 entitled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration,” in response to feedback and concerns raised by various sectors and stakeholders.
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
The Health Sciences Authority (HSA), Singapore, seeks public consultation on exemptions from manufacturer licensing and product registration requirements for Artificial Intelligence (AI) – Software as Medical Devices (SaMDs) developed by MOH Holdings Pte Ltd (MOHT), Synapxe Pte Ltd (Synapxe), and public healthcare clusters/institutions. Scope of AI-SaMD for Proposed Exemptions Class
The Thai Food and Drug Administration (FDA), through the Medical Device Control Division, has developed a document supplementation system to facilitate the upgrading of submission types from Partial 1, Partial 2, or Abridged to Full Common Submission Dossier Template (CSDT). This system is accessible via the TFDA’s Skynet platform and
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