On August 6, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released an overview to compare the latest medical device risk management requirements between China and the EU. Background Since 2014, the medical device registrants
The revised Regulations for the Supervision and Administration of Medical Devices (State Council Order No.739, hereinafter referred to as the Regulations) will be implemented as of June 1, 2021. NMPA is organizing the formulation and revision of supporting regulations, normative documents and te
To strengthen the supervision and guidance of medical device registration and further improve the quality of registration review, the NMPA organized to formulate the Guidance (Revision 2020) for Technical Review of Clinical Evaluation of Equivalent Devices of Medical Magnetic Resonance Imaging Syste
In September 2018, NMPA issued the Announcement on the Issuance of the Newly Revised Catalogue of Medical Devices Exempt from Clinical Trials, which comprehensively revised and summarized the previously published Catalog of medical devices (and in vitro diagnostic reagents) exempt from clinical t
To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on January 18, 2021 the Guidelines for Technical Review of the Registration of Mycoplasma Pneumonia
In order to strengthen the supervision and guidance over medical device registration and further improve the quality of registration review, the NMPA has organized to formulate 2 technical review guidelines for registration including the Guidelines for Technical Review of Clinical Evaluation of Ultr
To implement the requirements of the Provisions for Medical Device Adverse Event Monitoring and Re-evaluation (SAMR and NHC Order No.1), regulate and guide medical device registration applicants to write the periodic risk evaluation reports, NMPA has organized to formulate the Writing Specification
