In accordance with the new Thai FDA Change Notification guidelines, the Thai FDA has revised the amendment timeframes within the Change Notification System.
The updated requirement applies to newly submitted Change Notification applications starting from 20 April 2026.
Read the full press release here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
Purpose of the Press Release
To announce the revised document correction timeframe for Change Notification applications submitted through the Thai FDA Change Notification System.
To inform registrants and stakeholders of the shortened correction period applicable to newly submitted Change Notification applications.
Scope of Application
This update applies to newly submitted Change Notification applications starting from 20 April 2026.
It is relevant to registrants and stakeholders submitting medical device Change Notification applications to Thai FDA.
Current | New |
• Amendment allowed up to 2 times | • Amendments allowed up to 2 times |
• Correction period: Within 5 business days | • Correction period: Within 3 business days |
*** If the requested amendments are not submitted within the specified timeframe, the application status in the system will automatically change to “Returned from system” | *** If the requested amendments are not submitted within the specified timeframe, the application status in the system will automatically change to “Returned from system” |
The most significant change is the reduction of the correction timeframe from 5 business days to 3 business days.
Registrants and stakeholders are advised to establish a more agile internal review and coordination process to ensure that correction requests, supporting information, and revised documents can be prepared and resubmitted within the shortened timeline.
Delayed responses may increase the risk of automatic rejection or system return of the application.
Effective Date
20 April 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Thailand, please contact sales@andamanmed.com.