• 2020-11-27 02:07:10

This announcement applies to all registrants of foreign Class II and Class III medical devices that have been registered in China, through foreign manufacturers established in China.

• 2020-08-11 05:46:22

To standardize and guide medical device registrants to prepare periodic risk evaluation reports, NMPA has released a guidance to illustrate the required information and format in this special “PSUR”.

• 2020-06-16 08:03:29

NMPA released the Draft Revision of Guidance of Software for Medical Device Registration, which increased the scope of application, while paying more attention to the review of technical documents.

• 2020-06-11 09:48:40

NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.

• 2020-06-11 09:41:54

NMPA drafts a new guidance document of human factors (Usability) for medical device, the Class II and Class III devices are applicable once implementation. Now NMPA seeks for public comment.

• 2020-06-11 09:36:28

A new online submission system has been implemented for one year, and NMPA notifies that the agents should renew the CA as soon as possible to ensure the certificate validity.

• 2020-05-12 06:20:32

On 2011, China NMPA published the 1st edition of “Guidance of Adverse Event Monitoring for Medical Device”. Now, they make a dramatic change on the adverse event system and modify the guidance according.

• 2020-05-12 06:08:27

NMPA of China released the registration work report in April 2020, covering the milestones of medical device regulations and registration applications from last year. In addition to actively improving relevant regulatory regulations and standards, NMPA also gradually adjusts its internal operating methods.

• 2020-04-14 08:57:04

NMPA has revised the quality inspection measure of medical devices to show their determination on strengthening post-market surveillance. The worst-case scenario manufacturers may face in PMS would be total product recall.

• 2020-04-14 08:54:35

Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.