Who Makes It in China?
1,330 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 22 other provinces. 313 of them are contract manufacturers. Chinese manufacturers are registered for 75 of 121 device types here.
60 of those 75 device types need no premarket submission before sale in the United States. The FDA has recorded 705 recalls across the section’s product codes; the root causes it names most often are Process control (94), Nonconforming Material/Component (70) and Device Design (69).