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.
What the Innovation Plan Says
Composed of 10 parts and 34 detailed rules, the plan proposes the following:
- The creation of China’s only “global licensed drug insurance”－an innovative medical insurance payment method
- The construction of China’s only centralized storage bonded warehouse for overseas innovative pharmaceuticals and equipment that are not yet marketed in China
- The establishment of China’s only whole-process traceability platform for unlisted licensed drugs and medical devices
- The introduction of a new model of clinical real-world data (RWD) application for drug and device registration
- The mechanism of free cross-border capital flows
- The expedited approval time for healthcare facilities and engineering construction
- The facilitation for the diagnosis, treatment, entry, stay and residence of foreign medical staff, patients, and accompanying personnel
- The shortened licensing time for foreign and domestic doctors and nurses.
Urgent Use Policy & RWD
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.
How to Obtain RWD?
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:
- Data derived from electronic health records (EHRs)
- Medical claims and billing data
- Data from product and disease registries
- Patient-generated data, including from in-home-use settings
- Data gathered from other sources that can inform on health status, such as mobile devices.
- Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.