Who Makes It in China?
132 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Shanghai, and 14 other provinces. 22 of them are contract manufacturers. Chinese manufacturers are registered for 49 of 111 device types here.
24 of those 49 device types need no premarket submission before sale in the United States. The FDA has recorded 4,599 recalls across the section’s product codes; the root causes it names most often are Device Design (1,002), Software design (924) and Nonconforming Material/Component (334).