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2026 China NMPA Bluebook is here:
NMPA granted Innovative Device Approval to the CT Imaging Assisted Pulmonary Nodule Detection Software produced by Hangzhou Deepwise on December 1, 2020. This is the second
The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature.
The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Classification Catalog 2020 Complete
The NMPA announced its preparation of “Technical Review Guideline of Diagnostic Software for Diabetic Retinopathy (DR)” and “Technical Review Guideline of Image Ultrasonic Diagnostic Based AI
China’s UDI system for the submission of the first group of devices will take effect on January 1, 2021. For the medical devices listed in the
Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted
A “Beijing Medical Ethics Committee (EC) Review Mutual Recognition Alliance” was formed on December 1, 2020. The mutual recognition alliance currently consists of fifteen member
Unapproved medical devices can be clinically used in China’s Big Bay Area of Guangdong, Hong Kong, and Macao with over 70 million people. As long
The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020. For the NMPA Innovation Device Review
“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
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by
The NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on