Who Makes It in China?
139 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Guangdong and Jiangsu, and 14 other provinces. 31 of them are contract manufacturers. Chinese manufacturers are registered for 129 of 436 device types here.
105 of those 129 device types need no premarket submission before sale in the United States. The FDA has recorded 2,311 recalls across the section’s product codes; the root causes it names most often are Device Design (265), Nonconforming Material/Component (238) and Process control (162).