On April 25, 2023, NMPA CMDE, Hainan local NMPA, and Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration issued a notice on the release of the Implementation Measures for Pre-communication Work on Clinical Real World Data Application of Medical Device in Hainan Boao Lecheng International Medical Tourism Pilot Zone (trial version, No.14, 2023).
In 2019, Hainan Province government and the National Medical Products Administration (NMPA) jointly launched the pilot work of clinical real-world data application in Boao Lecheng International Medical Tourism Pilot Zone. At present, a standardized system, smooth operation mechanism and communication platform have been preliminarily established for the pilot work, which has a basis for regular implementation. In order to further strengthen the real-world data application work of medical devices and accelerate the real-world research work through the pre-communication service, Implementation Measures for Pre-communication Work of Clinical Real-world Data Application of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial) jointly formulated by Center for Medical Device Evaluation of National Medical Products Administration (NMPA CMDE), Hainan Medical Products Administration (Hainan local NMPA) and Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration is hereby issued.
Meanwhile, Hainan local NMPA formulated the Guidelines for Submission of pre-communication Dossiers for the Clinical Real-world Data Application of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone and Guidelines for Consulting Services for the Real-world Data Application of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone.
NMPA is enhancing the support of China real world study in Hainan and will provide consultations on the medical devices which have been approved as urgent use in Hainan, covering the technical and clinical issues raised by overseas manufacturers, and address such issues before NMPA acceptance.
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