关键词: 医疗器械, 标准, 创新, 发展

Abstract:

Since 2015， China has implemented a series of measures to encourage medical device industrial innovation， such as the reform of medical device review and approval system， implementing the medical device registration holder system， which have significantly promoted industry development. However， the industry still faces critical issues like product homogeneity and insufficient original innovation. Standardization serves as a foundational system for the modernization of national governance systems and governance capabilities， and it is an important technical basis for economic and social development. In recent years， China has issued a series of strategic documents to actively advance standardization efforts， aiming to lead industrial innovation and high-quality development. This study reviews the reforms， covering technical systems， organizational structures， and operational protocols， in medical device standardization framework under the current regulatory mechanism， such as supporting the development of standards in innovative fields， establishing specialized technical focal units for standardization， and implementing industry standards formulation and revision led by enterprises. It also clarifies how standards drive industry development， identifies challenges in current standardization practices， such as long revision cycles and insufficient support measures， as well as challenges like difficulties in new technology standard development， regulatory challenges， and balancing standard technological innovation with industrial stability. Recommendations include enhancing policy support， deepening mechanism reform， promoting the development of group standards， and widely applying new technology standards to further boost the role of standards in driving industry innovation and development.

Key words: Medical devices； , Standards； , Innovation； , Development