NMPA Notice on Issuing the Guiding Principles for Registration and Review of Clinical Evaluation of Electronic Endoscopes of the Same Variety

Recently, in order to further standardize the clinical evaluation of the same variety of electronic endoscopes, this guiding principle is written to guide the registration applicant to carry out the clinical evaluation of the same variety of electronic endoscopes, and also to provide a reference for the technical review department to review the clinical evaluation data of the same variety of electronic endoscopes

watching focus

Electronic endoscopes can be divided into bronchoscope, duodenal endoscope, choledochoscope, etc. According to the imaging dimension, it can be divided into two dimensional and three dimensional endoscopes. According to the number of use can be divided into disposable use and reusable electronic endoscopes; According to the connection mode of light source, it is divided into external light source and internal light source endoscope. Considering the diversity of electronic endoscopes, these guidelines are mainly for clinical evaluation of the image quality and operational performance of electronic endoscopes.