Who Makes It in China?
813 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 19 other provinces. 200 of them are contract manufacturers. Chinese manufacturers are registered for 97 of 114 device types here.
92 of those 97 device types need no premarket submission before sale in the United States. The FDA has recorded 423 recalls across the section’s product codes; the root causes it names most often are Device Design (82), Nonconforming Material/Component (55) and Component design/selection (31).