Who Makes It in China?
61 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Shanghai, and 8 other provinces. 17 of them are contract manufacturers. Chinese manufacturers are registered for 7 of 13 device types here.
4 of those 7 device types need no premarket submission before sale in the United States. The FDA has recorded 19 recalls across the section’s product codes; the root causes it names most often are Device Design (3), Labeling mix-ups (2) and Process control (2).