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Imported Medical Device Approval for China’s First Independent Province


“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”, announced by China State Council in April 4th.


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 the fabulous beaches.


Boao City, known for Boao Forum for Asia, has been established as a pilot district of international medical forum on February 2013. Soon afterwards, multiply 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 hospital 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).


But the rule has been changed now with the latest announcement.


“For any Class II and Class III imported medical device in China, the foreign manufactures shall submit the application and home country approval to CFDA for registration approval”, published by Medical Device Supervision and Regulations in March, 2014.


However, Hainan Province was exempted now, and the details of the new policy could be expected on Boao Forum on March 9-11.


The foreign drug manufacturers have already benefited from Hainan medical tourism policy: in September 2016, Hainan Cancer Hospital had successfully imported the Merck’s Keytruda (Pembrolizumab), a drug intended for non-cell lung cancer. It was only take half a month to get the registration from Hainan Province local FDA, compared to 3-5 years of clinical trials for traditional CFDA pathway.


Global hospital groups focused more on business opportunities: Medical institutions from US, Germany, Japan and Swiss invested $3.33 Billion US dollar in Hainan for the year of 2017 to concentrate in the stem cell trial, cancer treatments, anti-aging research and assisted reproductive technology (ART) applications.


Chinese citizens spent over $10 billion US dollar in oversea medical care in 2015. But as medical tourism becomes hot in Hainan Province, Chinese expanding middle and upper classes do not have to go oversea to get treatment, which will also help central government to retain the medical revenue in China.


About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.

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