China's Proposed Rules Expand Penalties for Medical Device Recalls

John Balzano participated in an FDAnews webinar and is quoted in an Inspection Insider article regarding China FDA’s proposed rules that increase penalties for devicemakers that fail to issue recalls. Commenting on the agency’s “accelerated pathway” for breakthrough medical devices, Balzano says that in order to be eligible for the pathway, the devices’ intellectual property must be held in China, and the device needs to represent an improvement over existing technology and be clinically significant.