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
To strengthen the supervision and guidance over medical device registration, and further improve the quality of registration review, NMPA has organized to formulate the Technical Review Guidance for the Registration of Disposable Breast localization Wire, Technical Review Guidance for the Regis
NMPA issued NEW Guidance ON PERIODIC RISK EVALUATION REPORTS OF MEDICAL DEVICE On July 2, NMPA released the updated guidanceofperiodic risk evaluation report for medical devices addressing the timescale and data collection scope for preparing and submitting the initial report:
Comparison and application of different immunoassay methods for the detection of SARS‐CoV‐2 CORRESPONDING AUTHOR:Yunfeng Lv Jingyun He | Peng Hu | Yu Gao| Shengwei Zheng| Chao Xu| Rongzhi Liu| Li Fang| Ran Li| Congyin Han| Juanjuan An| Jinchun Dong| Gang Deng| Lei Sun Abstract The detect
On March 17, 2020, NMPA issued the2019 Annual Report for Medical Device Registration, which covers five parts: medical device registration status, medicaldevice registration application acceptance status, medical device registration approval status, innovative medical device registration approval st
To strengthen medical device administration and standardize the sampling inspection of medical device quality, NMPA has organized the revision of and released on March 13, 2020 theAdministrative Measures for Sampling Inspection of Medical Device Quality. The Administrative Regulations on Quality Sup
