Which Manufacturers in China Work in This Section?
62 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 9 other provinces. 28 of them are contract manufacturers. Chinese manufacturers are registered for 27 of 48 device types here.
8 of those 27 device types need no premarket submission before sale in the United States. The FDA has recorded 151 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (36), Process control (16) and Material/Component Contamination (14).