Who Makes It in China?
50 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Zhejiang and Shandong, and 11 other provinces. 17 of them are contract manufacturers. Chinese manufacturers are registered for 48 of 271 device types here.
21 of those 48 device types need no premarket submission before sale in the United States. The FDA has recorded 392 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (119), Process control (41) and Device Design (21).