China's NMPA Gatekeeper: The In-China Domestic Agent Explained

Medical Device Global Market Access · Oct 14, 2025 · 3m

This episode demystifies the mandatory role of the In-China Domestic Agent for foreign medical device manufacturers entering the Chinese market. We explore the legal basis under State Council Order 739, effective June 1, 2021, and detail the agent's critical responsibilities in registration, NMPA communication, post-market surveillance, adverse event reporting, and recall management. Learn why selecting the right agent is a vital strategic decision for ensuring long-term regulatory compliance in China. Key Questions: • What is an In-China Domestic Agent and why is it mandatory for medical…