【CODEX】医疗器械网络安全注册技术审查指导原则-中英双语

医疗器械网络安全注册技术审查指导原则

Guideline for Technical Review of Medical Device Cybersecurity Registration

      本指导原则旨在指导注册申请人提交医疗器械网络安全注册申报资料，同时规范医疗器械网络安全的技术审评要求。

This Guideline aims at guiding the registration applicant to submit application dossiers for medical device cybersecurity registration and standardizing the requirements for technical review of medical device cybersecurity.

      本指导原则是对医疗器械网络安全的一般性要求，注册申请人应根据医疗器械产品特性提交网络安全注册申报资料，判断指导原则中的具体内容是否适用，不适用内容详述理由。注册申请人也可采用其他满足法规要求的替代方法，但应提供详尽的研究资料和验证资料。

This Guideline is the general requirements for medical device cybersecurity. The application dossiers for cybersecurity registration shall be submitted based on the features of medical device by the registration applicant who shall determine whether the specific content of the guideline is applicable and specify reasons if not. Other alternative approach that meets the regulatory requirements can also be adopted by the registration applicant, but detailed research data and validation material shall be provided.

      本指导原则是在现行法规和标准体系以及当前认知水平下、并参考了国外法规与指南、国际标准与技术报告制定的。随着法规和标准的不断完善，以及认知水平和技术能力的不断提高，相关内容也将适时进行修订。

This Guideline is formulated based on the current regulations, standard system and present cognitive level, with the reference of foreign regulations and guidance as well as international standards and technique reports. Along with constant improvement of regulations and standards as well as continuous enhancement of cognitive level and technological competence, the relevant content will be revised timely.

      本指导原则是对注册申请人和审评人员的指导性文件，不包括审评审批所涉及的行政事项，亦不作为法规强制执行，应在遵循相关法规的前提下使用本指导原则。

This Guideline is a guiding document for the registration applicant and the reviewer which excludes the administrative matters involved in the review and approval and cannot be implemented mandatorily as a regulation. It shall be used on the premise of complying with relevant regulations.

      本指导原则作为《医疗器械软件注册技术审查指导原则》的补充，应结合《医疗器械软件注册技术审查指导原则》的相关要求使用。本指导原则是医疗器械网络安全的通用指导原则，其他涉及网络安全的医疗器械产品指导原则可在本指导原则基础上进行有针对性的调整、修改和完善。

As a supplement to the Guideline for Technical Review of Medical Device Software Registration, this Guideline shall be applied in combination with relevant requirements of Guideline for Technical Review of Medical Device Software Registration. This Guideline is the general guidance for medical device cybersecurity. Other guidelines for medical device involving cybersecurity can be adjusted, modified and improved in terms of specific areas on the basis of this Guideline.

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