Which Manufacturers in China Work in This Section?
157 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Guangdong and Jiangsu, and 13 other provinces. 15 of them are contract manufacturers. Chinese manufacturers are registered for 10 of 12 device types here.
None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 41 recalls across the section’s product codes; the root causes it names most often are Process change control (13), Equipment maintenance (2) and Device Design (1).