Termination of Pre-Submission Stage
In April 2022, the Thai FDA terminated the so-called "pre-submission" stage. To streamline the review process, risk classification and grouping confirmation have been implemented from 2nd May 2022 onwards.
Online Submission Platform
Risk classification inquiry and medical device grouping inquiry must now be submitted exclusively via an online platform. The essential documents required for submission include:
- Product List (Thai FDA Template)
- Labeling (Latest update)
- IFU (Latest update)
- Product Description
- Other Documents (if any)
Please note that risk classification and medical device grouping must be filed separately and will incur a fee of 500 THB per submission.