The 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 evaluations, and
The NMPA Medical Device Standardization Administration released the second batch of results for medical device classification, excluding 86 products as medical devices. It also identifies 60 Class III, 94 Class
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 List: 15 medical devices are
[vc_row][vc_column][vc_column_text] [/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_custom_heading text=”Overview” use_theme_fonts=”yes”][vc_column_text]China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be based on the Device Category, Subcategory,
You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory
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