Which Manufacturers in China Work in This Section?
1,639 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 25 other provinces. 428 of them are contract manufacturers. Chinese manufacturers are registered for 283 of 441 device types here.
219 of those 283 device types need no premarket submission before sale in the United States. The FDA has recorded 6,146 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (1,005), Process control (858) and Device Design (434).