Which Manufacturers in China Work in This Section?
60 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Shanghai and Zhejiang, and 5 other provinces. 34 of them are contract manufacturers. Chinese manufacturers are registered for 97 of 192 device types here.
2 of those 97 device types need no premarket submission before sale in the United States. The FDA has recorded 6,535 recalls across the section’s product codes; the root causes it names most often are Device Design (1,252), Process control (640) and Nonconforming Material/Component (473).