• 2021-06-25 12:32:37

While the channel of distribution of a COVID-19 vaccine under the conditional approval scheme is rigorously controlled by the Thai FDA, a fast-track approval route was launched exclusively for more COVID-19 products even under the implementation of risk-classification regulation.

• 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

• 2021-05-22 03:15:45

Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. This marked a milestone for both establishments and the Thai FDA team.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.

• 2020-06-16 08:03:29

This draft of medical device definition for manufacturers and importers to follow when registering their medical devices according to risk-based classification, to emphasize the milestone transition of Thailand away from policy-based classification.

• 2020-06-16 05:04:48

Thailand is presently at the PHASE 3 transition, where businesses are reopening , Qualtech presents collection of the regulatory updates from ThaiFDA, in relation to COVID-19 kit outbreak.

• 0000-00-00 00:00:00

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

• 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

• 2020-04-14 12:02:03

Local health authorities in Asia Allow certain products to be exempted from the regular registration routes and, in some cases, even being eligible to be imported directly.

• 2020-02-21 06:56:50

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement on the Final Draft on Good Distribution Practice for Medical Devices 2020 will be hosted by Medical Device Control Division, Food and Drug Administrative.