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 or expedited approval in China? • How have clinical evaluation requirements been relaxed for certain devices? • What are the increased penalties for non-compliance under Order 739? • Why is the Unique Device Identification (UDI) system critical for post-market surveillance? • How does Order 739 impact foreign manufacturers specifically? • What new responsibilities do legal representatives and senior management now face? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.