The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number. more…
NMPA published “Clinical Evaluation Guideline on Comparing the Medical Imaging Ultrasonic Diagnostic Equipment with the Same Variety” on January 19, 2021. The 27-page document provides manufacturers detailed pathway for clinical evaluation, which is less time-consuming and more cost-effective than clinical trial. more…
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…
