In order to improve the normalization and scientificity of technical evaluation of medical devices and guide medical device registrants/filing entities to prepare product technical requirements, in accordance with the Regulations on Supervision and Administration of Medical Devices, Provisions for Medical Device Registration and Filing and Provisions for Registration and Filing of In-vitro Diagnostic Reagents, the National Medical Products Administration has organized the revision of the Guidance for Compiling the Product Technical Requirements for Medical Devices, which was issued on February 8, 2022.