• 2021-01-19 02:38:54

NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.

• 2020-11-27 02:19:08

Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.

• 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.

• 2020-06-16 07:38:56

In China, AI medical devices are evolving, and its regulatory system is also being developed rapidly. We have researched applications of AI to medical device and clinical assistance in China, as well as, outstanding Chinese AI companies and related AI products.

• 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.