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...
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...
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...
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...
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...
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...