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
On May 21, 2025, the Vietnam Ministry of Health issued Notification No. 387/TB-HTTB, officially announcing the relocation of the Infrastructure and Medical Device Administration (IMDA) office. The new IMDA office is now located on the 7th, 8th, and 9th floors of the Ministry of Health’s 9-storey building at Alley 1,
The Department of Health (DOH) posted an advisory on its DOH FB page last May 30, 2025, informing the public of its approval for the temporary suspension of FDA New Regulatory Fees. The approved FDA memorandum with Subject: Recommendation to temporarily suspend the implementation of Administrative Order 2024-0016: Implementing Guidelines
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