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The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for the equipment. Indication and composition
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature of Nerve and Cardiovascular Surgical
NMPA published “Clinical Evaluation Guideline on Medical Magnetic Resonance Imaging System with Same Variety” on February 1, 2021. The 16-page document provides manufacturers detailed pathway for clinical evaluation, which is
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
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