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2008-11-18 | All chapters
Announcement on Relevant Issues of Tags and Package Marks of Imported Medical Devices
Recently, some local FDAs reported the problem that the information of ‘Made in XX (country)’ on the original tags and package marks of imported medical devices are not consistent to the country claimed in the ‘Manufacturer Address’ registered on the medical device registration certificate, which is related to relevant Chinese regulations and international trade rules. In order to regulate the administration, SFDA clarifies the issues related to tags and package marks of imported medical devices.
近来，部分地方食品药品监管部门在工作中遇到进口医疗器械产品原文标签和包装标识中“Made in xx（国）”所标注的国家与该产品医疗器械注册证登记表中“生产场所地址”所标注的国家不一致的问题。涉及我国有关管理规定和国际贸易规则。为规范管理，现对境外医疗器械标签和包装标识管理有关问题明确如下：
1. In accordance to Article 48 of the Measure on Administration of Medical Device Registration (Ministerial Order 16) and Articles 5, 6 and 15 of the Regulation on Administration of Medical Device Manual, Tag and Package Mark (Ministerial Order 10), the words of the context of imported medical device manuals, tags and package marks must be in Chinese and other languages can be supplementary. The content must be identical to the content of the medical device registration certificates and manuals reviewed by SFDA.
依据《医疗器械注册管理办法》（局第16号令）第四十八条及《医疗器械说明书、标签和包装标识管理规定》（局第10号令）第五条、第六条和第十五条的相关规定，境外医疗器械说明书、标签和包装标识文字内容必须使用中文，可以附加其他文种；其内容应当与经国家食品药品监督管理局审查的医疗器械注册证书及说明书有关内容相符合。
2. With respect to relevant WTO rules, foreign medical device manufacturers should comply with international trade rules by noting the origins on some tags and package marks of the imported medical devices, e.g., the expression of ‘Made in XX (country)’, which may not be consistent to the countries mentioned in ‘Manufacturer Address/ Production Address’ on the Chinese tags and package marks. This situation does not violate the relevant provisions of Order 16 and Order 10
遵循WTO相关规则，境外医疗器械生产企业按照国际贸易规则，在其部分进口医疗器械标签和包装标识中标注的原产地国家，如“Made in xx（国）”等类似表述，可能与中文标签和包装标识中“生产场所地址/生产地址”所标注的国家不一致，该情形并不违反局第16号令和局第10号令的相关规定。
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http://www.sdpc.gov.cn/zcfb/zcfbtz/2008tongzhi/t20081113_245703.htm