• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

• 2020-02-21 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.

• 2020-02-21 07:11:04

On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " . The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances.

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 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.

• 2020-05-05 06:46:09

NMPA releases the registration approval power to other NMPA branch to enhance the foreign medical device access to China market. This action brings more opportunities for the foreign manufacturers to get product license and enter China market.

• 2020-02-12 14:09:42

China National Medical Product Administration (NMPA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. This revision will be effective on December 1, 2018.

• 2020-02-13 06:05:20

• 2020-02-14 04:20:17

China National Drug Administration (CNDA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. Drafts of the revision were released in early May and is currently open for public comments. This revision will be expected to take effect on October 1, 2018.