N M P A   R E G U L A T I O N S    

01-08

2023

Frequently Asked Questions about the registration of medical device and IVDs in China
Below you will find answers to questions we get asked by clients the most about registering medical devices or IVDs in China.1 Where can we access Chinese standards in English?There is still no off...

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...

03-30

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

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...

03-29

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...
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