Who Makes It in China?
292 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Shanghai, and 19 other provinces. 43 of them are contract manufacturers. Chinese manufacturers are registered for 67 of 109 device types here.
50 of those 67 device types need no premarket submission before sale in the United States. The FDA has recorded 767 recalls across the section’s product codes; the root causes it names most often are Packaging (121), Process control (111) and Nonconforming Material/Component (67).