N M P A   R E G U L A T I O N S    

01/11

2025

Announcement of the National Health Commission and NMPA on the Issuance of Temporary Import and Use Management requirements for Medical Devices in Urgent Need of Clinical Use in Medical Institutions (No. 97 of 2024)
In order to standardize the management of the temporary import and use of medical devices urgently needed by clinical institutions and further meet the urgent needs of clinical diagnosis and treatm...

08/30

2024

Hainan Free Trade Port Boao Lecheng International Medical Tourism pilot zone clinical urgent need for the management of imported drugs and medical devices
People's governments of cities, counties and autonomous counties, and units directly under the provincial government:The "Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zon...

03/30

2022

Interpretation of Quality Problems in Medical Device of Clinical Trials
1. One year validitytest report of medical device registration on clinical trial “Specification for quality management of medical deviceson clinical trials," Article VII: "quality inspection report...

03/30

2022

A Description of the Preferential Approval Procedure for Medical Devices
Issued on October 26, 2016A"medical device priority approval procedures"will be implemented on January 1, 2017,issued by the State Food and Drug Administration.17 procedures include the purpose and...

03/30

2022

Interpretations of the Relevant Issues Concerning the Special Approval of Innovative Medical Device
Issued on July 31, 2017 1. Application time for the special approval of innovative medical devicesAccording to the "Innovation Procedures", if the registrant has applied for the special approval of...

03/29

2022

Rules for Classification of In Vitro Diagnostic Reagent
1.In order to standardize the classification management of in vitro diagnostic reagents, these rules are formulated according to the Regulations on The Supervision and Administration of Medical Dev...