Which Manufacturers in China Work in This Section?
257 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 13 other provinces. 60 of them are contract manufacturers. Chinese manufacturers are registered for 43 of 112 device types here.
10 of those 43 device types need no premarket submission before sale in the United States. The FDA has recorded 3,221 recalls across the section’s product codes; the root causes it names most often are Process control (408), Nonconforming Material/Component (258) and Component design/selection (256).