On April 4, 2022, the Thai FDA released updated review timelines for medical device applications submitted through the e-submission portal. This comes a little over a year after the TFDA implemented their new regulations and provided their initial estimated review times. Now that there has been significant experience reviewing applications, the TFDA has the new timelines to help manufacturers better plan for market access. Additionally, the TFDA has broken out the review timelines to better represent the time it takes for various applications, including those submitted as Partial 2 vs. Full CSDT vs. Full CSDT with a Specialist Review. Previously, the TFDA had only provided the maximum review time per registration route i.e. Listing, Notification or License which included a Specialist Review and a full CSDT review, making the review times seem much longer than they actually were.

Please see our Thailand Medical Device Registration page for more information on the topic.

Updated Review Timelines in Thailand

* Partial 2 applications are only permitted until the end of 2023, when the transition period will end. It permits some products’ applications to be submitted with less (Partial) CSDT documentation.

** Specialist Reviews are determined at the discretion of the applications reviewer and is more likely among novel devices and applications with lacking documentation. 

Automatic Cancellation System Implemented

Additionally, the TFDA has also implemented a new cancellation system that will automatically cancel applications if they meet certain criteria. This criteria includes applications that require more than 4 corrections or have not been corrected within 30 days from receiving TFDA feedback.  This action will be taken for the applications submitted from February 1, 2022 onwards.