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China's Regulatory Overhaul: Your Guide to NMPA Order 739
This episode delves into the landmark revision of China's medical device regulations, State Council Order No. 739, which took effect on June 1, 2021. We break down the critical changes impacting global MedTech manufacturers, from the revolutionary Marketing Authorization Holder (MAH) system to new clinical evaluation pathways and heightened post-market responsibilities. Key Questions: • What is the new Marketing Authorization Holder (MAH) system and how does it change liability? • Can you now use your own company's testing data for NMPA submissions? • What are the new pathways for conditional…
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