On August 20, 2025, the Thai Food and Drug Administration (Thai FDA) issued Announcement (Issue No. 13) B.E. 2568 (2025), updating the list of experts, expert organizations, government agencies, and private organizations—both domestic and foreign—authorized to perform duties in evaluating academic documents for medical devices.
This announcement is made under Section 35/2, Paragraph One of the Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), together with Clause 8 of the Announcement of the Food and Drug Administration Office regarding the Criteria, Methods, and Conditions for Obtaining Experts, Expert Organizations, Government Agencies, or Private Organizations both Domestic and Foreign to Perform Duties in Evaluating Academic Documents for Medical Devices B.E. 2567 (2024), dated February 2, 2024.
Scope
The announcement concerns the official registration and authorization of experts, organizations, and agencies to carry out document evaluations that form part of the medical device registration and approval process in Thailand.
Key Changes
Addition of New Experts
The Thai FDA has added four academic experts to the roster of qualified evaluators:
- Associate Professor Nattawut Soemsathanosawat
- Associate Professor Natcha Yodrabam
- Assistant Professor Jirawat Sawangsri
- Associate Professor Worawit Wanichsuwann
Legal Basis
- Issued pursuant to Section 35/2 of the Medical Device Act B.E. 2551 (2008), as amended.
- Supported by Clause 8 of the FDA Announcement on criteria, methods, and conditions for obtaining evaluators (B.E. 2567 / 2024).
Effective Date
August 20, 2025
Implications for Clients
This update expands the pool of experts authorized to review academic and technical documentation for medical device registration and approval in Thailand. Manufacturers and importers can expect broader expertise and capacity in the review process, which may help streamline regulatory evaluations.
Read the Announcement
You can access the official text of the announcement here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
Next Steps
If you are preparing or submitting academic documentation as part of your medical device registration or renewal in Thailand, our regulatory team can assist you in navigating the updated expert review process.
Contact us at sales@andamanmed.com or click the button below for more details.
