• 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.

• 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.

• 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. 

• 2020-05-06 09:09:41

There is a lack of order and strong regulations in the procurement of medical consumables. China’s government has therefore issued measures to stabilize the currently chaotic situation.

• 2020-05-06 09:07:05

In the recent years, CMDE has started to adjust the internal workflow to optimize the registration process. In 2015, they have changed the structure of the reviewing department. This time, they have set up two different departments for a faster operation.

• 2020-05-06 08:22:59

The NMPA has issued the first global regulatory on the lifetime of active medical devices. This guideline provides various aspects on lifetime evaluation, and all manufacturers producing active medical device should carefully regards this specific issue.

• 2020-05-06 07:09:04

The regulations of examination for testing institutions in China have been changing for the past 2 years. Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.

• 2020-05-06 06:48:58

To enhance the efficiency of the registration process, NMPA sets up an online submission system. Local China agents of imported medical devices shall apply for an account within the system via Certificate Authority (CA) certificate. Further details are to be found below in this article.

• 2020-05-06 06:48:33

Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.