On June 1, 2021, the NMPA (National Medical Products Administration) issued the Catalogue of Technical Guidelines for Reviewing Medical Device Registrations.
As of May 2021, 399 technical guidelines have been issued in China, covering active medical devices, passive medical devices, in vitro diagnostic reagents, and real-world data application for the clinical evaluation of medical devices, the basic principles of the safety and performance of medical devices, naming of medical devices, and fast track approval of medical devices, etc.
The technical guidelines are intended to provide guidance to applicants preparing for the registration of their medical devices and the dossier submission materials.
By Jacky Li. Contact Cisema if you want to learn more.