Thailand: New submission process for screening application
- ARQon
- Sep 30, 2022
- 2 min read
The Thai FDA implemented a new submission procedure that will give an initial review of the provided documents and a response within 15 days as of August 1st, 2022 (official statement). Except for Class 1 applications, which are automatically approved, and Fast Track applications, the new procedure is applicable to all applicants. Following the recent implementation of their new medical device laws, the TFDA is now implementing improved procedures, such as inquiry response deadlines. This most recent update talks about the first actions the TFDA will do within 15 days of receiving a new application, which includes screening and reviewing it. The e-Submission platform must be used to submit all FDA applications in Thailand.
OVERVIEW OF THE NEW SUBMISSION PROCESS
Similar to a pre-submission process, the TFDA's screening and review will concentrate on the submitted papers rather than confirming classification and/or grouping strategy.
FIRST STEP: SCREENING
In accordance with the TFDA's check list, the screening stage will determine whether the documents are complete (English). The application will be rejected right away if the provided materials do not correspond to the stated themes. If all of the required paperwork is submitted, the TFDA will permit the application to move on to the review stage and will collect the submission fee.
SECOND STEP: REVIEW
The application will be allocated to the Reviewer after the submission fee transaction has been completed. The reviewer will evaluate the documents at this stage of the procedure for accuracy and proof of safety and efficacy.

If the TFDA officer discovers inaccurate or insufficient documentation, they will inform the registrant and provide them 15 calendar days, one time, to make the necessary changes. The application will be turned down if the adjustment cannot be made by the deadline. Any additional time needed after the application has been submitted for approval by the authority and for responding to expert feedback, should the application be subject to an expert assessment, is not included in the 15 calendar days.
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