Our Hainan program allows overseas medical devices, IVDs and drugs that have NOT been approved in China to be sold and used in real world clinical settings in Hainan province. This real-world data study of China clinical evaluation in the Hainan pilot zone will help urgent need medical devices.
Unapproved overseas products must meet certain criteria before they can be used in Hainan. Not all devices can be used here. But to use these devices, it’s necessary to apply through the urgent need use approval and importation process.
China Med Device offers turnkey solutions to perform the feasibility assessment and also to obtain the real world data approval for overseas manufacturers.
What Products are Qualified for Real World Study in Hainan
- NMPA unapproved products
- No predicates or better than predicates products in China
- Clinically significant
Why CMD should be your Hainan Partner of Choice
- The Hainan local office staffed with employees with proven clinical and regulatory experience
- Partnerships with key local government and commercial agencies
- Seasoned bi-lingual and bi-cultural staff for both clinical and commercial turnkey solutions
- We have 100+ years of combined management team experience
- Moreover, we hold 1000+ NMPA certificates
- On top of that, we have extensive relationships with the NMPA and China KOLs
What are the Benefits of Hainan Program for Overseas Manufacturers
- NMPA unapproved products can be used in Hainan in real world data clinical settings after urgent use approval.
- The urgent use approved products by Hainan can be promoted outside of Hainan throughout China. Patients can come from anywhere in China. However, treatments need to be done in Hainan, but follow-up can be done outside of Hainan.
- Eligible for fast track pilot program with national NMPA registration approval.
- Generating revenue immediately while collecting Real-World data (RWD).
- Products can be sold to directly to hospitals from overseas manufacturers.
- Imported and inventoried products in Hainan are considered duty-free.
Key Process for Hainan RWS