Which Manufacturers in China Work in This Section?
121 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Zhejiang, and 11 other provinces. 40 of them are contract manufacturers. Chinese manufacturers are registered for 52 of 62 device types here.
None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 1,089 recalls across the section’s product codes; the root causes it names most often are Device Design (260), Nonconforming Material/Component (105) and Process control (103).