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
On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits.
On April 17, 2025, the Food and Drug Administration (FDA) recognized the importance of enhancing competitiveness by developing public administration systems to provide efficient services to the public. Therefore, the electronic certificate system (e-Certificate) has been developed to meet the needs of entrepreneurs, allowing them to access services online anytime and
On 26 March 2025, the Medical Device Authority (MDA) announced the implementation of Circular Letter No. 1/2025, which supersedes Circular Letter No. 2/2014 regarding conformity assessment procedures for medical devices approved by recognised foreign regulatory authorities. This new circular was approved by the MDA Board and Top Management and took
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