Who Makes It in China?
191 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 18 other provinces. 27 of them are contract manufacturers. Chinese manufacturers are registered for 47 of 91 device types here.
None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 1,113 recalls across the section’s product codes; the root causes it names most often are Software design (316), Device Design (127) and Nonconforming Material/Component (108).