• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".

• 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.

• 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.

• 2020-05-06 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 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 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.

• 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.