Which Manufacturers in China Work in This Section?
1,070 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Zhejiang, and 18 other provinces. 263 of them are contract manufacturers. Chinese manufacturers are registered for 98 of 166 device types here.
56 of those 98 device types need no premarket submission before sale in the United States. The FDA has recorded 5,435 recalls across the section’s product codes; the root causes it names most often are Process control (927), Nonconforming Material/Component (715) and Device Design (570).