THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

• 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

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THAILAND: Thai FDA announcement regarding criteria for full evaluation and concise evaluation - November, 2019

• 2020-07-31 09:20:55

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.

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