医疗器械注册审查指导原则（以下简称指导原则）作为医疗器械技术审评的新工具、新方法、新标准，在提高科学审评能力、促进产业高质量发展进程中发挥着重要作用。器审中心坚持科学性原则，构建与我国医疗器械产业发展相适应的指导原则体系。
近年来，我国医疗器械指导原则体系建设工作成效明显，指导原则的质量和数量明显提升，指导原则结构布局不断优化。截至2023年底，我国指导原则制修订数量已达613项（详见附件），全方位、多角度地发挥对注册申报和技术审评的指导作用。器审中心将继续坚持努力提升指导原则的科学性、前瞻性和引领性。筑牢审评科学的技术文件根基，从而推动医疗器械监管效能，进一步助力、引导医疗器械产业高质量发展。
附件：
医疗器械注册审查指导原则目录（截至2023年底）.pdf
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The following is an unofficial translation
subject: Directory of guidelines for medical device registration review
The Guiding Principles for medical device Registration Review (hereinafter referred to as the Guiding Principles), as a new tool, new method and new standard for medical device technical review, plays an important role in improving the scientific review ability and promoting the high-quality development process of the industry. The center adheres to the scientific principle and builds a guiding principle system that is compatible with the development of China's medical device industry.
In recent years, the construction of China's medical device guiding principle system has achieved obvious results, the quality and quantity of guiding principles have been significantly improved, and the structure and layout of guiding principles have been continuously optimized. By the end of 2023, the number of amendments to the guiding principles system in China has reached 613 (see the annex for details), and it has played a guiding role in registration, declaration and technical review in an all-round and multi-angle manner. The Center will continue to make efforts to enhance the scientific, forward-looking and leading nature of the guiding principles. Build a solid foundation for the technical documents of the review science, so as to promote the efficiency of medical device supervision, and further help and guide the high-quality development of the medical device industry.
Annex: List of Guidelines for Medical Device Registration Review (by the end of 2023)
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