Which Manufacturers in China Work in This Section?
180 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Shanghai, and 12 other provinces. 47 of them are contract manufacturers. Chinese manufacturers are registered for 38 of 87 device types here.
9 of those 38 device types need no premarket submission before sale in the United States. The FDA has recorded 771 recalls across the section’s product codes; the root causes it names most often are Device Design (232), Nonconforming Material/Component (102) and Process control (94).