• 2020-02-21 06:52:42

Recently on November 13, NMPA had issued a notice on the suspension and rectification of a domestic manufacturing factory,, instructing the manufacturer to stop production until rectification is completed and approved by NMPA. On the other hand, nearly 30 manufacturers (domestic and foreign) initiated voluntary recalls of their products in November. Similar news has been cropping up in recent year, and it’s foreseeable that NMPA will keep strengthening the surveillancein the future.

• 2020-02-21 06:51:47

On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.

• 2020-02-21 06:49:55

In the past weeks, Qualtech has participated in the following three events: MEDICA in Germany, the Design of Medical Device Conference in Shanghai and the OMETA Seminar in Osaka.

• 2019-12-18 09:11:40

Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement will be hosted by Medical Device Control Division, Food and Drug Administrative.

• 2019-12-18 09:05:02

It is honor for Qualtech to receive an invitation from Hujing College, USST for the program ‘Training and Exchange of Precision Medical Innovation Technologies under the Background of Comprehensive Health’ in Shanghai, China from 25th November to 8th, December 2019.

• 2020-07-31 09:31:11

The announcement aims to set a standard and to ensure the direction for the authority in performing an evaluation of HIV screening kit by self-test application.

• 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.