NMPA published “Clinical Evaluation Guideline on 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
On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products. Mentioned in the guidelines, “the
Before July 21, 2021 the devices and drugs from Hongkong and Macao public hospitals can be clinically used in a Shenzhen Hospital, according to a joint announcement by Guangdong NMPA
By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in 2014. This “Green Pathway” can
The NMPA IVD guidelines included five updates on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. For
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
Here’s the latest NMPA regulatory and clinical affairs news for medical device and IVDs pros in December 2020. These updates are presented by China Med Device, LLC, your partner in
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 AI innovative product approved by
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 guidelines were put in
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
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 Software” for public comments on
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