Thailand: Updated Medical Device Application Review Timeline

ARQon
Jun 24, 2022
1 min read

The review timeline for the submission of medical device applications through e-submission portal has been newly revised and released by the Thailand Food and Drug Administration (TFDA) on 4 April 2022.

This is a follow-up to the new regulations implemented by the TFDA where they provide an initial estimated review time. This revision of the timelines aims to provide manufacturers with a better plan for market access. With experience of using the initial timeline, the TFDA can craft review timelines that more accurately reflects the time needed for various applications. Only the maximum review time per registration route was given previously, making application period seemed longer than needed.

Updates on Review Timeline

Implementation of Automatic Cancellation System

A new cancellation system has also been implemented to automatically cancel applications if more than 4 corrections are required or correction has not been made within 30 days after feedback from TFDA. This system applies to applicants made starting 1 February 2022.

Source:

Thailand FDA – Guidance on Change Notification for Medical Device (in Thai Language)