【CODEX翻译】接受医疗器械境外临床试验数据技术指导原则-中英双语

This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.

      本指导原则中涉及的境外临床试验数据是指，全部或同期在境外具备临床试验开展所在国家（地区）要求条件的临床试验机构中，对拟在我国申报注册的医疗器械在正常使用条件下的安全有效性进行确认的过程中所产生的研究数据。

二、接受境外临床试验数据的基本原则

II. Basic Principles for Acceptance of Overseas Clinical Trial Data

（一）伦理原则

(1) Ethical Principle

      境外临床试验应当遵循《世界医学大会赫尔辛基宣言》确定的伦理准则。申请人同时需说明采用的临床试验开展所在国家（地区）的伦理、法律、法规所制定的规范和标准，或国际规范和标准。

Overseas clinical trials shall abide by the codes of ethics determined by the World Medical Association Declaration of Helsinki. In addition, the applicant shall describe the norms and standards specified by the ethics, laws and regulations of the country (region) where the clinical trial is carried out, or international norms and standards.

（二）依法原则

(2) Legal Principle

      境外临床试验应当在有临床试验质量管理的国家（地区）开展，并且符合我国医疗器械（含体外诊断试剂）临床试验监管要求，若临床试验所符合的临床试验质量管理文件与《医疗器械临床试验质量管理规范》（GCP）有差异，应详细说明差异内容，并充分证明差异内容不影响研究结果的真实性、科学性、可靠性及可追溯性，且能够保障受试者权益。申请人及临床试验机构应接受国家食品药品监督管理总局的监督检查。

Overseas clinical trials shall be carried out in countries (regions) that implement quality management of clinical trials and meet the Chinese regulatory requirements for the clinical trials of medical devices (including IVD reagents). Any difference existing between the clinical trial quality management documents used in the overseas clinical trials and the Good Clinical Practice for Medical Devices (GCP) shall be explained in detail, and it shall be fully demonstrated that such difference will not affect the authenticity, scientificity, reliability and traceability of the research results and that the rights and interests of the subject are protected. The applicant and clinical trial institutions shall be subject to the supervision and inspection of the China Food and Drug Administration.