Which Manufacturers in China Work in This Section?
442 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Guangdong and Jiangsu, and 19 other provinces. 54 of them are contract manufacturers. Chinese manufacturers are registered for 51 of 108 device types here.
48 of those 51 device types need no premarket submission before sale in the United States. The FDA has recorded 594 recalls across the section’s product codes; the root causes it names most often are Process control (93), Process design (60) and Device Design (56).