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China NMPA Newsletter – March 2022

2022-05-04

Featured Articles Impacts From China Standard Update On Medical Device Registration During the whole process of medical device…

NMPA Gives Full Support To China Real World Data Application Pilot Projects

2022-04-27

On April 22, 2022, NMPA published a Communication Procedure for Medical Device Real World Data Application Projects in…

Key Updates In New Version Of China GMP Compared With Old Version

2022-04-12

On March 22, 2022, NMPA published the updated version of China GMP (Good Manufacturing Practice) and GSP (Good…

China New GCP Effective Since May 1, 2022

2022-04-01

On March 31, 2022, NMPA officially released China new GCP (Medical Device Clinical Trial Quality Management Provisions, i.e.,…

Impacts From China Standard Update On Medical Device Registration

2022-04-01

During the whole process of medical device lifecycle, the standards will be updated periodically. For example, GB 9706.1-2020…

China NMPA Newsletter – February 2022

2022-04-01

Featured Articles NMPA Approval Summary Of Medical Devices In 2021 In 2021, NMPA approved 11,314 items of initial…

China Qualified Medical Device Clinical Sites Summary In 2021

2022-03-28

Since the promulgation and implementation of the Measures for the Administration of Medical Device Clinical Trial Institutions Conditions…

Interpretation Of Relevant Regulatory Documents And Response Strategies On China National Medical Device Quality Sampling And Inspection Work In 2022

2022-03-23

In recent years, with the national policy and the continuous adjustment and optimization of the industrial structure around…

NMPA Updated Guidelines On Software, Cybersecurity And AI

2022-03-17

On March 7, 2022, NMPA published the updated Registration Review Guidelines on Medical Device Cybersecurity (Revision 2022), Registration…

NMPA Approval Summary Of Medical Devices In 2021

2022-03-15

In 2021,NMPA approved 11,314 items of initial registration, renewal registration and change registration of medical devices, an increase…

NMPA Acceptance Summary Of Medical Device Registration Application In 2021

2022-03-02

NMPA Acceptance Summary of Medical Device Registration Application in 2021 In 2021, NMPA accepted 12,255 applications for initial…

China NMPA Newsletter – January 2022

2022-02-28

Featured Articles NMPA New Regulatory Framework Summary In 2021 In 2021, China NMPA established new regulatory framework for…