• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.

• 2020-06-16 08:03:29

PFDA publishes new guidelines regarding License to Operate (LTO)-related transactions for establishments.

• 2020-06-16 05:36:31

This is a specific pre-clinical testing guidance for products classified under Powered wheelchair in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data. The overall pre-clinical test data should include inspection specifications, methods, original records, and results.

• 2020-06-16 05:19:05

To ensure the safety and efficiency of adopting human factors/usability engineering evaluation while manufacturer developing medical devices, this guidance provided an overall concept and guide, including product design, development, registration, and post-market related matters.

• 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.

• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.

• 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 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.

• 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.