Hainan Island New Device Release Increases Gateway To China

On April 22, the NMPA’s Center for Medical Device Evaluation (CMDE) and the Hainan Medical Product Administration (MPA) announced the Hainan Communication Standard Operating Procedure (SOP) for Medical Device Clinical Real-World Data Applications. This announcement details the regulatory process to register non-approved medical devices at qualified hospitals on Hainan Island. The foreign applicant can discuss the registration with the Hainan MPA. China’s NMPA will also review the preliminary information and ask applicants for supplementary data. Then the CMDE will provide feedback to the Hainan MPA, and the applicant will use this feedback to finalize their application to the Hainan MPA for approval to import non-registered medical devices of an urgent need to Hainan Island. Real-world data generated on Chinese patients from Hainan Island can then be used for China’s approval with the NMPA.