The Hainan Provincial NMPA, the Hainan Health Commission, and the Haikou Customs jointly issued the “Optimizing Regulatory Services to Support the High-Quality Development of Hainan Boao Medical Tourism Pioneer Zone” on September 15, 2021. The document is intended to simplify the approval process of clinically urgently needed imported drugs and medical devices and improve the government service.
The foreign-approved devices for urgent Chinese clinical needs, without predicates approved in China, 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.
Over the three years, more than 100 medical devices and drugs have been imported to Hainan, including some represented by China Med Device.
Key Changes in Hainan Boao
Significant changes have been made to facilitate the faster approval of medical devices in Hainan:
- Qualified medical institutes can import instead of the original few. Qualification include having specialized department, good supplying practice system and well-trained professionals to deal with adverse events, etc.
- Approved institutes can submit the importation request online.
- Classify the imported devices based on home-country standards, if difference occurs with Chinese classification.
- Annual filing and digital traceability platform.
- Encourage the commercial insurance system used by medical institutes.
- After national NMPA approval, the unapproved intended use can continue the clinical urgent usage.
- Timeline: ten working days for institutes qualification, three working days for device approval from health commission, and seven working days for device check from the Hainan NMPA.
- Most important one: patients can take certain drug and equipment back home to use.
For our service page on Hainan Real-World Data/Study, please click HERE
For the webinar on Fast-Track Your Initial Clinical Use in China with the Hainan RWD/S Pilot Program, please click HERE