Who Makes It in China?
217 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Zhejiang, and 13 other provinces. 62 of them are contract manufacturers. Chinese manufacturers are registered for 66 of 168 device types here.
29 of those 66 device types need no premarket submission before sale in the United States. The FDA has recorded 1,399 recalls across the section’s product codes; the root causes it names most often are Device Design (213), Nonconforming Material/Component (191) and Process control (173).