Who Makes It in China?
168 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Jiangsu, and 16 other provinces. 41 of them are contract manufacturers. Chinese manufacturers are registered for 22 of 37 device types here.
14 of those 22 device types need no premarket submission before sale in the United States. The FDA has recorded 118 recalls across the section’s product codes; the root causes it names most often are Device Design (27), Process control (12) and Labeling mix-ups (4).