Which Manufacturers in China Work in This Section?
619 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Jiangsu, and 18 other provinces. 154 of them are contract manufacturers. Chinese manufacturers are registered for 79 of 134 device types here.
45 of those 79 device types need no premarket submission before sale in the United States. The FDA has recorded 2,780 recalls across the section’s product codes; the root causes it names most often are Process control (374), Device Design (360) and Nonconforming Material/Component (225).