The National Medical Products Administration and the Provincial Government issued the "Implementation Measures for Pre-communication of Clinical Real World Data Application of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial)"

In 2018, the State Council granted the Hainan Provincial People's Government the right to approve the import of clinically urgently needed medical devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as Lecheng Pilot Zone). In 2019, four departments jointly issued a document proposing that real-world data generated during the use of clinically urgently needed medical devices in Lecheng Pilot Zone can be used for product registration. In 2019, the National Medical Products Administration launched the Regulatory Science Action Plan and included the application of clinical real-world data of medical devices in key research projects. At present, real-world evidence can be used for clinical evaluation of medical devices, including eleven common situations.
Since the Hainan Provincial People's Government and the National Medical Products Administration jointly carried out the pilot work of clinical real-world data application in Boao Lecheng International Medical Tourism Pilot Zone in 2019, a standardized system, smooth operation mechanism and communication platform have been initially established, which has the basis for normalization. In order to further deepen the application of real-world data of medical devices, better accelerate the promotion of real-world research (hereinafter referred to as real research) through pre-communication services, and continuously promote the reform of the medical device review and approval system, this method is specially formulated.
1. Work Objectives
The Medical Device Technical Evaluation Center of the State Drug Administration (hereinafter referred to as the National Medical Device Evaluation Center), the Hainan Provincial Medical Products Administration (hereinafter referred to as the Hainan Provincial Bureau) and the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration (hereinafter referred to as the Lecheng Administration) jointly build a medical device real research pre-communication service system with early intervention, full guidance and instant communication, and jointly create a ministry-provincial collaborative joint construction work mechanism to further promote the implementation of medical device real research and promote the normalization and institutionalization of real-world data for registration decision-making.
2. Scope of Application
This measure applies to clinically urgently needed imported medical devices that comply with the "Regulations on the Management of Clinically Urgently Needed Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port", and the real-world research of medical devices for product registration in the Lecheng Pilot Zone, and the products confirmed by the Hainan Provincial Bureau to be included in the pre-communication service.
3. Responsibilities of each party
(I) National Medical Device Evaluation Center
Provide technical and talent support. Provide guidance on the pre-communication service for medical device research and development of Hainan Provincial Bureau, select technical backbones to carry out publicity and training, support and participate in communication and exchanges, and assist in the training of relevant professionals of Hainan Provincial Bureau.
(II) Hainan Provincial Bureau
Organize and carry out pre-communication service for medical device research and development, publicize and implement medical device research and development policies, implement project management, and regularly communicate and exchange with the National Bureau's Medical Device Evaluation Center.
(III) Lecheng Administration Bureau
Cooperate in the publicity and training of medical device research and development policies, and assist Hainan Provincial Bureau in project management. Build and operate the information management platform according to needs.
IV. Workflow
(I) Applicants submit pre-communication applications
Applicants submit pre-communication service applications to Hainan Provincial Bureau in accordance with the pre-communication materials submission guidelines. The pre-communication materials submission guidelines shall be separately formulated by Hainan Provincial Bureau.
(II) Hainan Provincial Bureau confirms the inclusion of pre-communication
Hainan Provincial Bureau reviews the service applications submitted by applicants, and includes them in the pre-communication services if they meet the pre-communication materials submission guidelines.
(III) Conduct pre-communication
1. First communication meeting
For those included in the pre-communication, the Hainan Provincial Bureau will promptly organize the first communication meeting to communicate with the applicant on the spot, and may invite the National Bureau's Medical Device Evaluation Center to provide technical guidance.
2. Mid-term guidance
During the pre-communication period, the applicant may apply for communication and provide relevant supporting materials in accordance with the procedures. The Hainan Provincial Bureau will promptly organize research and reply. The National Bureau's Medical Device Evaluation Center will promptly provide guidance on more complex technical issues; and will regularly review the issues answered by the Hainan Provincial Bureau.
3. Final communication meeting
Before the product registration application, the Hainan Provincial Bureau will organize the final communication meeting to communicate with the applicant on the spot, and may invite the National Bureau's Medical Device Evaluation Center to provide technical guidance.
4. End pre-communication
For those that have been accepted by the National Bureau's Medical Device Evaluation Center for registration, the Hainan Provincial Bureau will end the relevant services and report to the National Bureau's Medical Device Evaluation Center on a regular basis.
(IV) Pre-exit communication
Pre-exit communication should be conducted in the following circumstances:
1. The applicant actively applies for withdrawal;
2. The project is not advanced as planned;
3. There are serious violations in the research behavior, or the research data is untrue;
4. Other circumstances that should be withdrawn.
The Hainan Provincial Bureau shall promptly report the withdrawal situation in writing to the National Medical Device Evaluation Center.
V. Work requirements
(I) Strengthen organizational leadership
The National Medical Device Evaluation Center, Hainan Provincial Bureau and Lecheng Administration Bureau set up a joint working group to strengthen unified leadership, strengthen organizational management, and ensure efficient and orderly progress of work. The person in charge of the National Medical Device Evaluation Center serves as the team leader, and the person in charge of the Hainan Provincial Bureau and Lecheng Administration Bureau serves as the deputy team leader. The joint working group regularly summarizes the work, evaluates the implementation effect, and puts forward suggestions for improvement.
(II) Improve the internal management mechanism
All units should strengthen the internal management mechanism, formulate operating specifications, determine the division of responsibilities, clarify work requirements, optimize work procedures, improve work efficiency, strictly enforce work discipline, keep work secrets, and ensure high-quality and efficient work.
(III) Strengthen project management
Each unit shall implement project management for the work it implements. Establish a work log, track project progress, strengthen supervision and inspection, and ensure that the work forms a closed loop. Accelerate the construction and timely improve the information platform for pre-communication services for medical device research.
(IV) Strengthen communication and exchange
The three parties shall establish a smooth communication and exchange mechanism and exchange information in a timely manner. The Hainan Provincial Bureau shall regularly report the progress of work to the National Bureau's Medical Device Evaluation Center, and the National Bureau's Medical Device Evaluation Center shall provide guidance.
(V) Strengthen talent training
The National Bureau's Medical Device Evaluation Center shall strengthen business training for the Hainan Provincial Bureau and the Lecheng Administration Bureau, and strengthen personnel exchange and training.