NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally accepted standard, NMPA stated in the notice. more…
Center for Medical Device Standardization Administration NMPA released the “second batch results of medical device classification”, excluding 86 products as medical devices. It also identifies 60 Class III, 94 Class II and 49 Class I medical devices, and 23 devices parts and 4 as combination devices. 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 Needle-free Injectors. 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 ECMO more…
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…
