Who Makes It in China?
498 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Zhejiang, and 18 other provinces. 111 of them are contract manufacturers. Chinese manufacturers are registered for 102 of 307 device types here.
62 of those 102 device types need no premarket submission before sale in the United States. The FDA has recorded 2,568 recalls across the section’s product codes; the root causes it names most often are Process control (385), Nonconforming Material/Component (308) and Device Design (283).