From NMPA to FDA: Leveraging China Approval for U.S. Market Entry

Medical Device Global Market Access · Sep 3, 2025 · 4m

This episode details the process for medical device manufacturers to obtain FDA 510(k) clearance in the United States after securing Class III approval from China's NMPA. We explain that there is no direct reciprocity and outline how to strategically leverage existing Chinese technical documentation, clinical data, and testing reports. The focus is on conducting a thorough gap analysis to meet the FDA's unique requirements, particularly the concept of "substantial equivalence" to a predicate device and compliance with 21 CFR Part 820 for quality management systems. • Does my NMPA Class III…