BFA (Boao Forum for Asia Annual Conference) of 2018 is taking place as planned from April 8 to 11. On the first day of the forum, the State Council - China’s cabinet - announced the decision on suspending the implementation of the article 11, paragraph 2 of “the Supervision and Administration of Medical Device regulation” (Order 650) in the special area BMTPZ (Hainan Boao Lecheng International Medical Tourism Pilot Zone) for those devices with urgent need and without equivalent device within China.
Boao is a semi-fishing and semi-farming town with rivers, lakes, sea, mountains, and isles located in the east of Qionghai city, Hainan province subject to a tropical monsoon climate. It is the permanent venue for the BFA conference. Hainan, the southernmost province of China, welcomes its 30 years’ anniversary of status as a province and a special economic zone in China.
Approved in 2013 by the State Council, BMTPZ is the first of its kind in the country. Since 2015, it enjoys nine preferential policies, including faster approval for the import of medicines and medical devices as well as permission for overseas investment in establishing medical organizations in the zone and sometimes with a lower tariff. This decision is to further boost its medical tourism industry as part of the “One Belt One Road” initiatives.
According to the decision, it will be the local Hainan Government instead of the central CFDA to approve the devices to be used within designated healthcare institutions. CFDA will change the role to support Hainan Government drafting the rules and guidance for this process. The intention obviously is to speed up the product approval and the pilot progress to make sure patients within this area could receive the most advanced treatment available in the world. We would expect it to be the fast landing point for innovative import device manufacturers and it might also save them the cost for pre-market clinical trials. Generation PMCF data from this early market entry might potentially facilitate further distribution of the products into other regions in China. Qserve will continue to monitor the progress and will keep you informed in future blogs & newsletters.
You might also be interested in this blog: Boao BMTPZ provisional rules for import device published