中国创新医疗器械特别审批程序介绍(顾汉卿)新版特别审.pptxVIP

中国创新医疗器械特别审批程序介绍Introduction to Special Approval Procedure on China’s Innovative Medical Devices中国生物医学工程学会 顾汉卿Chinese Society of Biomedical Engineering Gu Hanqing随着科学技术的进步，医疗器械在临床疾病的预防、诊断、治疗中的作用越来越显得重要。为了鼓励医疗器械的研究与创新，让更多创新的高科技医疗器械快速受惠于普通百姓，中国食品药品监督管理局颁布了《创新医疗器械特别审批程序（试行）》。With the progress of science and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more important. To encourage research and innovation in medical devices, so that more innovative high-tech medical devices to rapidly benefit ordinary people, the State?Food?and?Drug?Administration (SFDA) issued Special Approval Procedure on Innovative Medical Devices (trial). I. Which products are innovative medical devices that can declare special approval? 一、哪些医疗器械产品属于创新医疗器械，可以申报特别审批。同时符合下列四点的产品属于创新医疗器械范围。The products meeting the following four points are innovative range of medical devices. 1.申请者在中国依法拥有申报产品核心技术的发明专利权，或者依法通过受让取得在中国发明专利权或其使用权；或者核心技术发明专利的申请已由国务院专利行政部门公开。 1）The applicant according to the law have the right of invention patent on declaring core technology in China, or according to the law?through the transferee?obtain the patent right for?invention?or?the right to use in China; or the application of invention patent on core technology has been published by the patent administration department under the State Council. 2.产品主要工作原理/作用机理为国内首创，产品性能或者安全性与同类产品比较有根本性改进，技术上处于国际领先水平。 2. The main?working principle?/?mechanism of products are the first in the country. Product performance or safety compared with similar product has a fundamental improvement, with technically a leading international level. 3.该产品具有显著的临床应用价值。 3. The product has significant?value in clinical application. 4. Have finished the preliminary research of the product and finalized the designed product. The process of study is real and controlled, with data?integrity?and traceability. 4.已完成该产品的前期研究并具有基本定型产品，研究过程真实和受控，研究数据完整和可溯源。 二、创新医疗器械特别审批获得通过，有哪些优惠政策? II. What are the?preferentia