Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement will be hosted by Medical Device Control Division, Food and Drug Administrative.
More The announcement aims to set a standard and to ensure the direction for the authority in performing an evaluation of HIV screening kit by self-test application.
More Thailand FDA is expedient to have amend Announcement regarding the criteria for Full Evaluation and Concise Evaluation dated on October 4, 2019. This amendment aims to be appropriate and consistent with the current situation of the expanding medical device industry.
More ThaiFDA sturdily believes that via the implementation of Good Distribution Practice for Medical Devices, manufacturers, importers and distributors must comply to ensure quality, safety and performance throughout the supply chain.
More National Committee on Prevention and Solution for AIDS concerned the important of individual infected situation. Encouragement of an action by increasing access Self-diagnosis of HIV infection which will be an essential key that will lead to the end of the AIDS problem.
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PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.
More The Act aims to specify Medical Device Control in accordance with the ASEAN Agreement on Provisions Medical instruments. As well as refresh the Act to suit the transformation of medical device industry, where all citizen can embrace standardized and qualified medical device.
More The Act aims to specify Medical Device Control in accordance with the ASEAN Agreement on Provisions Medical instruments. As well as refresh the Act to suit the transformation of medical device industry, where all citizen can embrace standardized and qualified medical device.
More ThaiFDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.
More The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.
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