Hainan government published “The System Integration Innovation Reform Plan of Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port”, unveiling first-of-its-kind policies on permission to import drugs and medical devices. Importation Processing time of foreign registered drugs and devices, indicated for clinical urgent needs, are shortened to three working days.
The Boao pilot zone was established in 2013 to pilot development of international medical tourism-related businesses and services in Hainan Island, about 32 times the size of Hong Kong. The preferential policies include licensed medical treatment, cancer prevention and treatment, health management, care and rehabilitation and anti-aging medicines.
China Med Device is the sponsor and China session leader for RAPS every year. In RAPS 2020, we collaborate our partners (Professor Xin Sun as RWS expert) and J&J to share our experiences in China registration and do more help on overseas medical device manufacturers for China entry.
For RAPS 2020 slides on China NMPA Regulatory and Clinical Affairs Key Updates which include latest Hainan policy, please email info@ChinaMedDevice.com.
Composed of 10 parts and 34 detailed rules, the plan proposes the following:
The foreign-approved devices for urgent Chinese clinical needs can be imported to Hainan via the policy dated back to April 2018. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA. For our latest review of Hainan RWD program, please click HERE.
Over the two years, over 100 medical devices and drugs have been imported to Hainan, including four represented by China Med Device, according to press release from Hainan government on June 9, 2020.
On December 13, 2019, NMPA issued the “Guideline on Real-World Data (RWD) Used in Medical Device Clinical Evaluation (Draft).” The document specifies the sources of RWD as following: