Distributors Required to Self-Assess Facilities in China

The CFDA has required many class II and III medical device distributors to self-assess their facilities by July 15, 2016. This policy was previously applied to drug distributors in order to eliminate bad distributors and has now been expanded to include medical device distributors. After companies assess their suppliers, GSP requirements, and other technical details such as packaging and labeling, they must report any problems to the CFDA and begin resolving their issues. Failure to report an issue or submission of falsified data will result in consequences such the loss of their distribution license.