• 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.

• 2020-05-06 01:40:30

CMDE has made the necessary adjustments to pave way for a faster process in obtaining clinical trial approval. Prior to these changes, the applicant shall wait for CMDE’s go signal before starting the clinical trial procedure. With this change, the applicant may already start conducting the clinical trial, given some conditions.

• 2020-05-05 07:10:38

With more and more medical device manufacturers engaging into the AI field, China government has started to draft related guidance document to support these firms in building up feasible regulatory strategic plans for their products employing deep learning technologies.

• 2020-05-05 06:52:56

Due to a number of queries received from manufacturers concerning which category would their products fall under, NMPA has drafted a list of principles which aims to help applicants categorize their antimicrobial-containing medical device products.