N E W S   A N D  R E G U L A T I ON S

01-08

2023

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

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

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

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

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...

06-13

2024

Release time: 2024-05-20The Notice mainly includes four parts.1 Expand the scope of the alliance and form a national alliance for centralized procurement.2 Strengthen overall planning and coordinat...

06-13

2024

Release time: 2024-05-11In order to strengthen the classification management of medical devices, further standardize the classification and definition of medical devices, and optimize the working p...

06-13

2024

NMPA Release time: 2024-05-11In order to implement the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739) and further g...
T H E   B R A N D  W E   S E R V E
Adaltis (Italy)
Common Sense (Israel)
DIASource (Belgium)
Medistim ASA (Norway)
Dr. Arabin (Germany)
Coroneo Inc (Canada)
Agilent
LSI Solutions (US)
Biomerica (US)
Reskin (Belgium)
Holland Trade Medical LTD
Care of Sweden AB (Sweden)
Pemco Inc. (US)
I2A (France)
Arterys (US)
Alfa Gate