09-Apr-18, China Med Device
"Imported medical devices can be clinically used in Boao City, Hainan province without CFDA registration approval, as long as they are approved by Hainan Province FDA office," the China State Council has announced.
%20China%20Med%20Device.jpg "China first province for imported medical device approval (c) China Med Device")
Image: China Med Device
The groundbreaking policy is to attract western device manufacturers, investors and medical tourists into Hainan, which is the very southern province of China and famous for its beaches.
Boao City was established as a pilot district of international medical forum in February 2013. Soon afterwards, multiple incentive policies were granted: selected stem cell trial was permitted, major medical equipment was used in private hospital, overseas capital was allowed to invest in hospitals and to deduct tariffs for medical devices and pharmaceuticals, etc. But none of the previous policies cross the CFDA bottom line – the only authorized state department to approve imported devices (Class II & Class III).