中国创新医疗器械特别审批程序介绍(顾汉卿)-新版特别审批

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• 受理创新医疗器 • After accepting the application for 械注册申请后, registration of 应当将该注册申 innovative medical 请项目标记为 devices, the registration items “创新医疗器 械”,并及时进 shall be marked as "innovative medical 行注册申报资料 devices", and 流转。 register to declare information flow in a timely manner.
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.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。
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.
• 已受理注册申报 • 的创新医疗器械, 食品药品监管总 局医疗器械技术 审评中心应当优 先进行技术审评; 技术审评结束后, 食品药品监管总 局优先进行行政 审批。
For the innovative medical devices that have been declared to accept the registration, Center for Medical Devices Evaluation, SFDA should give priority to the technical review; after the technical evaluation, SFDA is priority to administrative approval.
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 preferential policies for passing the special approval of innovative medical devices?
• 申请人所在地食 • 品药品监督管理 部门应当指定专 人,应申请人的 要求及时沟通、 提供指导。在接 到申请人质量管 理体系检查(考 核)申请后,应 当予以优先办理。
三、申报创新医 疗器械特别审批 应准备哪些资料? III. What information should be ready for declaring the special approval of innovative medical devices?
1.申请人企 业法人资格证 明文件; 2.产品知识 产权情况及证 明文件; 3.产品研发 过程及结果的 综述;
supervision and inspection according to the process of clinical trials.
• 在产品注册申请受理• Before accepting an 前以及技术审评过程 application for registration of the product 中,食品药品监管总 and in the process of 局医疗器械技术审评 technical review, Center 中心应当指定专人, for Medical Device 应申请人的要求及时 Evaluation of SFDA shall designate someone, at the 沟通、提供指导,共 request of the 同讨论相关技术问题。applicant, provide guidance for timely communication and discuss the related technical problems.
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
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。
I. Which products are innovative medical devices that can declare special approval?
• 同时符合下列 • The products meeting 四点的产品属 the following four points are innovative 于创新医疗器 range of medical 械范围。
• 医疗器械检测机构 • 应当在接受样品后 优先进行医疗器械 注册检测,并出具 检测报告。
Testing institution for medical devices shall make a registration test for medical devices in priority after accepting samples , and issue the report.
1.Legal person qualificat ion certificates of the applicant; 2.Intellectual property information and supporting documents of products; 3.Summary of product development process and results;
• 医疗器械检测机 • When testing institution 构在进行注册检 for medical devices 测时,应当及时 conducting registration test, 对生产企业提交 should pre-evaluate timely 的产品标准或技 product standards or 术要求进行预评 technical requirements 价,对存在问题 submitted from companies; on the existing problems of 的,应当及时向 the companies, shall be 生产企业提出修 timely proposed 改建议。 amendments.
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.
• 企业可以通过申请与审 评中心指定专人就以下 问题进行沟通交流: 1. 重大技术问题; 2. 重大安全性问题; 3. 临床试验方案: 4. 阶段性临床试验结果 的总结与评价; 5. 其他需要沟通交流的 重要问题。
• Enterprises can apply for communicating with designated person of Evaluation Center on the following issues: 1. Major technical problems; 2. Major safety issues; 3. Clinical trial schemes; 4. Periodic summary and evaluation of the results of clinical trials; 5. The other important issues that need to communicate.
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.
The local food and drug supervision and administration authority shall appoint someone, at the request of the applicant, provide guidance for timely communication. Upon receipt of the applicant to check the quality management system (assessment) application, should be given priority.
• 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 • With the progress of science and 中的作用越来越显得 technology, medical devices in the 重要。为了鼓励医疗 role of clinical disease prevention, diagnosiswk.baidu.com and treatment is more and 器械的研究与创新, more important. To encourage 让更多创新的高科技 research and innovation in medical 医疗器械快速受惠于 devices, so that more innovative hightech medical devices to rapidly 普通百姓,中国食品 benefit ordinary people, the 药品监督管理局颁布 State Food and Drug Administration 了《创新医疗器械特 (SFDA) issued Special Approval Procedure on Innovative Medical 别审批程序(试 Devices (trial). 行)》。
• 创新医疗器械的临 • Clinical trials of innovative medical devices shall be in 床试验应当按照医 accordance with the 疗器械临床试验相 requirements of related 关规定的要求进行, regulations on clinical trials 食品药品监督管理 of medical devices. The 部门应当根据临床 food and drug supervision 试验的进程进行监 and administration 督检查。 department shall make
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