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【CODEX】2014 No.4 医疗器械注册管理办法(1-4)-EN

医疗器械注册管理办法

Provisions for Medical Device Registration


第一章 总 则

Chapter I General Provisions


第一条 为规范医疗器械的注册与备案管理,保证医疗器械的安全、有效,根据《医疗器械监督管理条例》,制定本办法。

Article 1.The Provisions is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices, with a view to standardizing the administration of medical device registration and filing and guaranteeing the safety and effectiveness of medical devices.


第二条 在中华人民共和国境内销售、使用的医疗器械,应当按照本办法的规定申请注册或者办理备案。

Article 2.All medical devices sold and used within the territory of the People's Republic of China shall apply for registration or filing according to the Provisions.


第三条 医疗器械注册是食品药品监督管理部门根据医疗器械注册申请人的申请,依照法定程序,对其拟上市医疗器械的安全性、有效性研究及其结果进行系统评价,以决定是否同意其申请的过程。

Article 3.Medical device registration refers to the prescribed procedures conducted by the food and drug regulatory authority upon an application submitted by the registration applicant to decide whether the medical device to be marketed can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.

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