CHINESE JOURNAL OF MEDICINAL GUIDE >
Research on the Application of High-Quality Invention Basis in Medical Device Evaluation
Received date: 2025-09-08
Revised date: 2025-11-11
Accepted date: 2025-12-24
Online published: 2026-01-26
In recent years， the innovation pace of medical devices in China has accelerated， ushering in a period of vigorous development. From the perspective of pre-market evalution of medical device， this article expounds on the role and significance of the basis for subject selection and invention， summarizes the positioning of the invention basis of pharmaceuticals and medical devices by international organizations， and sorts out and analyses the registration application requirements for the invention basis by medical device regulatory authorities in China， the United States， the European Union and Japan. To encourage more innovative medical devices oriented to clinical value and centered on patients to be marketed， this article puts forward countermeasures and suggestions from three aspects. Firstly， from the downstream， regulatory authorities need to guide upstream registration applicants to pay attention to the quality of medical device project initiation by establishing relevant requirements of registration application materials. Secondly， for medical devices with disruptive and iterative innovative technologies， the evaluation institutes should optimize the allocation of research and review linkage resources， provide pre-event and in-event services， and enhance the quality and efficiency of the evaluation of innovative medical devices. Thirdly， the competent authorities for scientific research， evaluation institutes， clinical institutions and research institutions should work together to promote regulatory science research， providing decision-making references and capacity reserves for the early， safe and effective approval of innovative technologies in the medical field.
Key words： Medical device； ; Invention basis； ; Design and development； ; Registration applications
ZHANG Qi
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Research on the Application of High-Quality
Invention Basis in Medical Device Evaluation
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