Which Manufacturers in China Work in This Section?
37 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Beijing, and 4 other provinces. 12 of them are contract manufacturers. Chinese manufacturers are registered for 11 of 59 device types here.
7 of those 11 device types need no premarket submission before sale in the United States. The FDA has recorded 1,559 recalls across the section’s product codes; the root causes it names most often are Device Design (354), Nonconforming Material/Component (224) and Process control (181).