The need for special registration (NMPA) in China for foreign medical device and pharmaceuticals is one of the main factors inhibiting international companies from entering the Chinese market.
Last year, the Chinese government implemented policy changes, allowing to provide medical treatment based on FDA/CE approvals, in a designated medical zone in Hainan. This new policy enables fast introduction of innovative treatments to Chinese patients, first in Hainan and later leverage it to all of China.
This opportunity already attracted dozens of international companies to initiate the regulatory process in Hainan, among them, Medtronic, Johnson & Johnson, Allergan and more. Now, the Hainan government is officially inviting Israeli life-science companies to apply the process.