www.fdanews.com/articles/177309-china-says-device-distributors-must-conduct-self-inspections
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China Says Device Distributors Must Conduct Self-Inspections
June 29, 2016
China’s FDA is requiring distributors of Class II and III devices to conduct self-inspections and report on their business activities.
Manufacturers with distribution hubs in China will need to conduct audits of their distributors to ensure they are compliant.
The move is yet another measure the agency is taking to consolidate the market, because it believes the reports will expose non-compliant manufacturers.