• 2025-10-27 04:30:17

List of selected frequently asked questions regarding the renewal of the medical device approval certificates. Originally in Thai, this English version offers practical guidance for maintaining compliance with Thai FDA requirements.

• 2025-08-25 05:57:23

Thai FDA has announced a significant update to the renewal process for Class 2, 3, 4 medical device certificates, effective from 22 July 2025. This reform introduces streamlined procedures, with automatic renewals for full CSDT dossiers and differentiated requirements for Partial pathway registrations. By reducing unnecessary document submissions, the Thai FDA aims to balance regulatory efficiency with patient safety.

• 2024-11-04 10:27:21

Starting from 1 January 2025, Local Responsible Persons must submit Medical Device Listing Renewal Applications between 12 weeks and 1 year before the expiry of their listing approval. Applications that fail to reach MDD before the 12-week mark will not be processed.

• 2022-11-29 01:33:07

During quarter 4 of 2022, Thai FDA has announced the registration certificate renewal protocol and procedures. Medical devices with specific announcements for which CSDT have been practiced under the old policy-based regulation, will expire on 31st December 2022 and shall timely proceed with license renewal accordingly.

• 2021-11-24 09:26:58

As we approach the end of the year, Thai FDA published a renewal guideline for licensed and notified medical device manufacturing and importation licenses that will be expired on 31 December 2021. To continue to engage in their respective activities, manufacturers and importers shall comply with this guideline within 1st October to 31st December 2021.

• 2020-11-26 10:42:10

Food and Drug Administration has arranged and announced a set of documentation required for Seller's License renewal that will expire on December 31st, 2020. Seller's Licensee shall refer to this license renewal statement letter and prepare documents accordingly to prevent any mistakes while submitting leading to an efficient submission.

• 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

• 2020-02-14 04:17:02

In order to optimize the efficiency of approval process, China Drug Administration (CNDA) has proposed amendments for submission documents for the renewal and clinical trial application of medical devices. This notice was issued at the end of May.