Seminar on Medical Device Evaluation

2023-12-08 | Beijing

This seminar delved into topics such as the reform of the medical device evaluation and approval system, the U.S. medical device standard system, the latest progress in the application of real-world data in Hainan, and the unified evaluation standards of the Center for Medical Device Evaluation (CMDE). The following are the main outcomes of this seminar.

Deputy Director General DENG Gang of the CMDE gave an opening speech.

1. Deepening the Reform Ideas of the Medical Device Evaluation and Approval System

Director JIA Jianxiong provided a detailed introduction to the concepts of medical devices, registration, evaluation and approval. He also discussed the overview and basic regulatory situation of the Chinese medical device industry, emphasizing the importance of encouraging innovation in medical devices and sharing the latest progress in related work.

2. Introduction to the U.S. Medical Device Standard System

Assistant Country Director Scott GONZALEZ introduced the standards and qualification plans of the U.S. FDA, emphasizing the cooperation and exchange between China and the U.S. in the field of medical device regulation. He also answered participants' questions.

3. Latest Progress in the Application of Real-World Data in Hainan

Deputy Director GU Xiaofang provided a detailed overview of the background, practice, pilot results, and future prospects of Hainan's research on the application of clinical real-world data. She emphasized the importance of the implementation of pre-communication methods for medical devices and shared the outlook for conducting research on the application of real-world data in Hainan.

4. Introduction to the Unified Evaluation Standards of the Center for Medical Device Evaluation (CMDE)

Director ZHANG Shiqing introduced relevant content about unified technical evaluation standards, aiming to ensure the fairness and accuracy of the evaluation work.

5. Introduction to the Haikou National High-Tech Industrial Development Zone

In the afternoon session, participants learned about the overview and development history of the Haikou National High-Tech Industrial Development Zone.

6. Boao Lecheng Pilot Zone for Medicine: Policies and Practices

Director General JIA Ning shared the medical policies and practices of the Boao Lecheng Pilot Zone, including its development process, core policies and practices, and the "Five Platforms" development direction.

7. Development and Future Outlook

Director General ZHU Ning summarized the work of the Hainan Medical Products Administration and looked ahead to future development. She emphasized the innovation and development potential of Hainan Province in the field of medical devices, offering recommendations to strengthen regulation and promote innovation.

8. Jessica Yuan concluded the seminar by expressing gratitude to all the guests and participants for their valuable contribution, support, and active engagement in the event.

This seminar provided valuable opportunities for participants to exchange ideas and learn, contributing to the healthy development of the medical device industry.