• 2020-05-12 08:17:52

Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020, in order to gradually promote the transition of Thailand future regulation implementation.

• 2020-05-12 08:06:46

In order to tackle the threat of COVID-19, PMDA takes some measures to speed up the development of medical products for COVID-19. Now, timeline for clinical trials are shortened and IRB meeting are allowed to be held in unconventional ways.

• 2020-05-12 07:39:23

Health Sciences Authority (HSA) ensure the availability of respiratory devices for COVID – 19 patients. HSA placed flexible regulations such as allowing the use of emergency ventilators, clarifying the applicable change notification category that will not require approval and demonstrating the means for adding new model of respiratory devices.

• 2020-05-12 07:03:38

We discuss the different types of cosmetic implants and the key drivers to their ever-increasing market growth. We focused on the fastest growing market share, ASEAN, and the top players in the different types of implants.

• 2020-05-12 07:00:43

Health Sciences Authority (HSA) ensures the availability of test kits for the detection and diagnosis of COVID – 19. For these devices, a provisional authorization process is implemented, which can be done via email and be responded by HSA within three (3) working days.

• 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.

• 2020-05-12 06:20:32

On 2011, China NMPA published the 1st edition of “Guidance of Adverse Event Monitoring for Medical Device”. Now, they make a dramatic change on the adverse event system and modify the guidance according.

• 2020-05-12 06:08:27

NMPA of China released the registration work report in April 2020, covering the milestones of medical device regulations and registration applications from last year. In addition to actively improving relevant regulatory regulations and standards, NMPA also gradually adjusts its internal operating methods.

• 2020-04-14 12:11:36

On March 11, 2020 ThaiFDA announced the revocation of the License holder of 24 Alcohol-Based Hand Sanitizers which does not contain more than 70 % of alcohol by its volume in order to assure the public that Alcohol-Based Hand Sanitizers in the market meet ThaiFDA qualification, containing no less than 70 % of alcohol by its volume.

• 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.