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 more…
On June 20, 2023, NMPA approved for the registration application of the cutting-edge medical device, the “Head and Neck X-ray Stereotactic Radiosurgery System,” manufactured by ZAP Surgical Systems, Inc. BradyKnows provides the turnkey solution to this innovative device, covering registration, type testing, clinical trial, clinical evaluation, post market surveillance and other aspects of the whole life cycle. more…
On June 14, 2023, Intuitive Fosun’s “Thoracic and Abdominal Endoscopic Surgery Control System” appeared in the delivery information of medical device approval documents on the website of the National Drug Administration. Registration Certificate number “National Instrument Registration Licence 20233010800”. more…
