【CODEX】创新医疗器械特别审查程序-中英双语

创新医疗器械特别审查程序

Special Review Procedure for Innovative Medical Devices

第一条　为了保障医疗器械的安全、有效，鼓励医疗器械的研究与创新，促进医疗器械新技术的推广和应用，推动医疗器械产业发展，根据《医疗器械监督管理条例》《医疗器械注册管理办法》《体外诊断试剂注册管理办法》等法规和规章，制定本程序。

Article 1 This Procedure is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Medical Device Registration and the Provisions for In-Vitro Diagnostic Reagent Registration in order to ensure the safety and effectiveness of medical devices, to encourage the research and innovation of medical devices, to accelerate the promotion and application of new technologies for medical devices and to promote the development of the medical device industry.

第二条　符合下列情形的医疗器械审查，适用于本程序：

Article 2 The medical device review in any of the following circumstances is applicable to this Procedure:

（一）申请人通过其主导的技术创新活动，在中国依法拥有产品核心技术发明专利权，或者依法通过受让取得在中国发明专利权或其使用权，创新医疗器械特别审查申请时间距专利授权公告日不超过5年；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，并由国家知识产权局专利检索咨询中心出具检索报告，报告载明产品核心技术方案具备新颖性和创造性。

(i) If the applicant owns the invention patent of the core technology of the product in China through its leading technological innovation activities, or obtains his patent right or right of use in China by means of transfer in accordance with law, the application time for the special review of innovative medical devices shall be no more than five years from the date of patent authorization; Or, the application for the invention patent of core technology has been publicized by the patent administration department under the State Council, and a search report stating that the core technology protocol of the product is novel and creative is issued by the Patent Search and Consultation Center of SIPO.

（二）申请人已完成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。

(ii) The applicant has completed the preliminary research of the product with the result of a nearly finalized product. The research process is authentic and controlled, and the research data is complete and traceable.

（三）产品主要工作原理或者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，且具有显著的临床应用价值。

(iii) The main working principle or mechanism of action of the product is the first of its kind appeared in China. The product performance or safety is fundamentally improved compared with equivalent products and technologically, the product is at an international leading level and has a significant value in clinical application.

      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司，作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商，CODEX科译拥有更多的医学资深语言专家，能实现40多种语言对的互译，接受更高难度的医学领域的项目挑战，并在最短时间内适应以给出最合理的解决方案。保证最高质量，100%按时交付，高效、完善的售后保障是CODEX科译给客户的用心承诺。