• 2020-07-31 09:20:55

Thailand FDA is expedient to have amend Announcement regarding the criteria for Full Evaluation and Concise Evaluation dated on October 4, 2019. This amendment aims to be appropriate and consistent with the current situation of the expanding medical device industry.

• 2019-12-18 09:23:28

Through efficient teamwork and an outstanding cooperation, Sunmax and Qualtech obtained the first approval for Sunmax’s collagen facial implant product in China in the year 2014.

• 2019-12-18 09:22:33

Qualtech will discuss the latest trend of medical device regulations and share the latest information of China’s regulation in overseas medical device regulation seminar on December 13th, 2019, in Osaka. 

• 2019-12-18 09:21:23

In this issue, we have included China registration experience, along with some information on United States FDA and Europe’s requirement for high-risk cosmetic implants.

• 2019-12-18 09:20:34

We are happy to announce the opening of our Qualtech USA (QTU) office. The office is located in South Pasadena, California.

• 2020-07-31 10:02:04

Products Containing Alcohol for Humans, Animals Sterilization and Medical Device have now joined the family of Notified Medical and will be implemented in March 2019.

• 2020-07-31 09:47:43

In accordance to the Announcement Injectable Hyaluronic Acid for Skin Correction is classified as medical device to be licensed and will be implemented in March 2019.

• 2020-07-31 09:41:41

ThaiFDA announces that alcohol-based products for hygienic purposes are required to be Notified. This is expected to come into force by March 2020.

• 2020-07-31 10:08:37

ThaiFDA sturdily believes that via the implementation of Good Distribution Practice for Medical Devices, manufacturers, importers and distributors must comply to ensure quality, safety and performance throughout the supply chain.

• 2020-07-31 10:23:22

National Committee on Prevention and Solution for AIDS concerned the important of individual infected situation. Encouragement of an action by increasing access Self-diagnosis of HIV infection which will be an essential key that will lead to the end of the AIDS problem.