Thai FDA terminated the so-called “pre-submission” stage during April 2022. Hence, in order to reduce the lengthy process of Thai FDA reviewing, the risk classification and grouping confirmation have been implemented starting from 2nd May 2022 onwards.
The risk classification inquiry and medical device grouping inquiry shall only be submitted via an online platform. Essential documents to be submitted are as follows:
1. Product List (ThaiFDA Template)
2. Labelling (Latest update)
3. IFU (Latest update)
4. Product Description
5. Other Documents (if any)
Risk classification and medical device grouping shall be separately filed and charged. The government payable fee is 500 THB per submission.
Thailand FDA - Manual of Risk Classification Inquiry and Medical Device Grouping Submission