【CODEX翻译】关于第一类医疗器械备案有关事项的公告-中英双语
关于第一类医疗器械备案有关事项的公告-中英双语
Notice on Issues Concerning the Filing of Class I Medical Devices
《医疗器械监督管理条例》（国务院令第650号）自2014年6月1日起施行。根据条例，第一类医疗器械实行产品备案管理。现就第一类医疗器械（含第一类体外诊断试剂）备案有关事项公告如下：
Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) will be effective as of June 01, 2014. According to the Regulations, Class I medical device is subject to filing administration. The relevant issues concerning the filing of Class I medical devices (including Class I in-vitro diagnostic reagents) are hereby notified as follows:
一、 第一类医疗器械备案
（I）Filing of Class I medical devices
(一) 医疗器械备案是指食品药品监督管理部门对医疗器械备案人（以下简称备案人）提交的第一类医疗器械备案资料存档备查。
(I)The filing of medical devices is a process that the filing entity of medical device (hereinafter refers to as the filing entity) submits the filing documents for Class I medical devices to the food and drug regulatory authority and the food and drug regulatory authority files the filing documents submitted by the filing entity.
(二) 实行备案的医疗器械为第一类医疗器械产品目录和相应体外诊断试剂分类子目录中的第一类医疗器械。
(II) The medical devices subject to filing refer to the medical devices listed in the catalogue of Class I medical devices and the Class I in-vitro diagnostic reagents listed in the sub-catalogue of classification of in-vitro diagnostic reagents.
境内第一类医疗器械备案，备案人向设区的市级食品药品监督管理部门提交备案资料。进口第一类医疗器械备案，备案人向国家食品药品监督管理总局提交备案资料。香港、澳门、台湾地区医疗器械的备案，参照进口医疗器械办理。
To apply for filing of domestic Class I medical devices, the filing entity shall submit the filing documents to the food and drug regulatory authority of the city consisting of districts. To apply for filing of overseas Class I medical devices, the filing entity shall submit the filing documents to China Food and Drug Administration. The medical devices from Hong Kong, Macao and Taiwan shall be filed by reference to the overseas medical devices.
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