【CODEX】临床急需医疗器械附带条件批准上市的基本原则

（征求意见稿）

临床急需医疗器械附带条件批准上市的基本原则 （征求意见稿）

Basic principles of conditional approval for market authorization of medical devices urgently needed for clinical use

(Draft for Comments)

第一章 总则

第一条 为支持和鼓励申请人对治疗严重危及生命且尚无有效治疗手段疾病以及公共卫生方面等急需的医疗器械（以下简称“临床急需医疗器械”）的研发，加快该类医疗器械上市，依据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），结合我国医疗器械注册管理相关要求及注册审评工作实践制定本基本原则。

Article 1  In order to support and encourage the applicant to research and develop medical devices urgently needed for the treatment of severe life-threatening diseases without effective treatment at present and public health (hereinafter referred to as "medical devices urgently needed for clinical use" ), and to speed up the marketing authorization of such medical devices, these basic principles are formulated in accordance with the Opinions on Deepening of Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (No. 42 [2017]) of the General Office of the CPC Central Committee and the General Office of the State Council, and in combination with the relevant requirements of the registration management of medical devices in China and the practice of review and registration.

第二条 本基本原则适用于经《治疗严重危及生命且尚无有效治疗手段疾病及公共卫生方面等临床急需医疗器械的确定程序》确定的拟申请附带条件批准上市的临床急需医疗器械注册申请。

Article 2  The basic principles are applicable to the registration application of the medical devices urgently needed for clinical to be applied for conditional approval which are defined in accordance with Procedure for Determining Medical Devices Urgently Needed for Clinical Use for the Treatment of Severe Life-Threatening Diseases without Effective Treatment at Present and Public Health”.

第三条 对治疗严重危及生命且尚无有效治疗手段疾病及公共卫生方面等临床急需医疗器械，监管机构应充分考虑医疗器械上市后预期收集的数据与上市前已收集的数据之间的平衡性，综合上市前后数据形成的风险受益比，从而合理保证其安全性和有效性符合医疗器械相关法规要求。

Article 3  For medical devices urgently needed for the treatment of severe life-threatening diseases without effective treatment at present and public health, the competent authorities shall give full consideration to the balance between the post market data of medical devices expected to be collected and the pre-market data, and integrate the risk-benefit ratio formed by the pre-market and post market data, so as to reasonably ensure that the safety and effectiveness of the medical devices meet the requirements of relevant laws and regulations.

第四条  从“临床急需”的论证证据，到附带条件的设立，再到上市后数据的收集，附带条件批准上市虽然对医疗器械临床试验的要求有灵活性，但并未降低医疗器械安全有效性整体评价的要求。

Article 4  From the evidence for demonstration of "urgently needed for clinical use" to the establishment of collateral conditions, to the collection of pre-market data, although the requirements for conditional approval of medical devices urgently needed for clinical use for marketing authorization are flexible, but does not reduce the overall evaluation of the safety and effectiveness of medical devices.

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