Pre-communication for Hainan medical device clinical RWD (real-world data) applications will be required to follow the measures announced (No.14 of 2023) by the Center for Medical Device Evaluation (CMDE) on April 25, 2023, for trial implementation. The trial measures will play an important role on enhancing the application of real-world data and accelerating medical device research.
In 2019, the Hainan Provincial People’s Government and the National Medical Products Administration (NMPA) jointly launched a pilot project for the application of real-world data in the Boao Lecheng International Medical Tourism Pioneer Area. The pilot project has already established a standardized system, smooth operation mechanisms, and communication platforms, laying the foundation for regular development.
Objectives of the trial measures
The Measures highlight the collaborative efforts of the CMDE of the NMPA, the Hainan MPA, and the Lecheng Administration. The goal is to establish a pre-communication service system that facilitates early intervention, comprehensive guidance, and real-time communication for medical device research. Through this joint working mechanism, the three parties aim to promote the normalization and institutionalization of real-world data for registration decision-making.
Scope of application
The Measures apply to clinical urgent import medical devices that comply with the regulations on the management of imported drugs and medical devices urgently needed for clinical use in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pioneer Area. These medical devices are intended for real-world research in the Lecheng Pioneer Area and have been confirmed by the Hainan Provincial Drug Administration to be eligible for pre-communication services.
Responsibilities of all parties
- The NMPA provides technical support and expertise, guides the pre-communication service of medical device research in the Hainan Provincial Administration, conducts training and professional development, and assists in technical guidance and support for the project.
- The Hainan MPA organizes and implements the pre-communication service for medical device research, disseminates and implements relevant policies, manages the project, and maintains regular communication with the NMPA.
- The Lecheng Administration collaborates in training and implementing policies related to medical device research, supports the project management efforts of the Hainan MPA, and establishes and maintains the necessary information management platform.
- Application for pre-communication:
- Applicants submit their requests for pre-communication service to the Hainan Provincial Bureau, adhering to the guidelines for submission of pre-communication materials.
- Hainan Provincial Administration confirms inclusion in pre-communication:
- The Hainan Provincial Administration reviews the service application submitted by the applicant and includes it in pre-communication services if it meets the pre-communication Data Submission Guidelines.
- Conduct pre-communication:
- First meeting
- For those included in pre-communication, the Hainan Provincial Administration promptly organizes the first meeting for on-site communication with the applicant.
- Mid-term coaching
- During pre-communication, the applicant can apply for communication and provide relevant supportive materials in accordance with procedures.
- Last meeting
- Before submitting the product registration application, the Hainan Provincial Administration organizes the final meeting for on-site communication with the applicant.
- End of pre-communication
- For those who have obtained registration acceptance from the NMPA, the Hainan Province Administration ends the related services and reports regularly to NMPA.
- First meeting
- Withdrawal from pre-communication:
The following situations require exiting pre-communication:
- Applicant voluntarily applies for exit;
- The project does not progress as planned;
- There is serious misconduct in research behavior, or research data is not truthful;
- Other situations in which withdrawal is required.
The Hainan Province Administration shall promptly report the exit situation to the National Bureau of Instrumentation and Metrology Center in writing.
Read the original CMDE announcement on the pre-communication trial measures for Hainan medical device clinical RWD application.
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