NMPA’s CMDE announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI Software” for public comments on December 31, 2020. feedback needs to be submitted by Jan. 31, 2021. more…
China UDI system for the first group of devices will take effect on January 1, 2021. For the medical devices listed in the “First Group of Unique Device Identification Devices”, when applying for the initial registration, registration renewal or the change of registration, the applicant or registrant shall submit the unique identifier of unique device identification (hereinafter referred to as UDI-DI) in the registration management system. more…
Your feedback counts! China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers must follow. To address the technical requirements during the application and further guide the registration review of more…
Your feedback counts! China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers must follow. To address the technical requirements during the application and further guide the registration review of CT Imaging Assisted Pulmonary Nodule Detection Software, more…
On December 28, a kick-off meeting for the fast track pilot drugs and medical devices was held in Beijing. At the meeting, Hainan fast track pilot program officially kicked off the first batch of drugs and the second batch of medical devices, more…
“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong and Macao, and have advanced clinical applications, which can be approved by the Guangdong Provincial Government”, more…
