Hainan Real-World Data/Study

Now You Can Sell in China Before Approval with Real World Data

What is Hainan Program?

Hainan program allows overseas medical devices, IVDs and drugs that have NOT approved in China to be sold and used in real world clinical settings in the Hainan province.

Unapproved overseas products must meet certain criteria before they can be used in Hainan. Not all devices can be used in the province. To use these devices, it is necessary to apply through the Urgent need use approval and importation process.
CMD offers turnkey solution to not only perform the feasibility assessment but also obtain the approval for overseas manufacturers.

What Products are Qualified for Hainan Program

  • NMPA unapproved products
  • No predicates or better than predicates products in China
  • Clinically significant

Why CMD should be your Hainan Partner of Choice

  • Hainan local office staffed with employees with proven clinical and regulatory experience
  • Partnerships with key local government and commercial agencies
  • Seasoned bi-lingual bi-culture staff for both clinical and commercial turnkey solutions
  • 100+ years of combined management team experience
  • 1000+ NMPA certificates
  • Extensive relationship with NMPA and China KOLs

What are the Benefits of Hainan Program for Overseas Manufacturers

  • NMPA un-approved products can be used in Hainan in real world clinical setting 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 outside of Hainan.
  • Eligible for fast track pilot program with national NMPA registration approval
  • Generating revenue immediately while collecting Real-World data (RWD)
  • Products sold to directly to hospitals from overseas manufacturers
  • Imported and inventoried in Hainan duty free

Key Process for Hainan RWS