国家食品药品监督管理总局令
Order of China Food and Drug Administration

第 4 号

No. 4

《医疗器械注册管理办法》已于2014年6月27日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2014年10月1日起施行。

Adopted at the meeting of CFDA dated June 27, 2014, these Provisions are hereby promulgated, and shall take effect as of Oct. 1, 2014.

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　局　长　张勇

Director ZHANG Yong

2014年7月30日

July 30, 2014

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 are 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 conduct 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 marked can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.

医疗器械备案是医疗器械备案人向食品药品监督管理部门提交备案资料，食品药品监督管理部门对提交的备案资料存档备查。

Medical device filing is a process that the filing applicant submits the filing documents to the food and drug regulatory authority and the food and drug regulatory authority files the filing documents submitted by the filing applicant.

第四条    医疗器械注册与备案应当遵循公开、公平、公正的原则。

Article 4   The medical device registration and filing shall be conducted under the principles of publicity, equity and justice.

第五条    第一类医疗器械实行备案管理。第二类、第三类医疗器械实行注册管理。

Article 5   Class I medical device is subject to filing administration and Class II and Class III medical devices are subject to registration administration.