【CODEX】2014 No.4 医疗器械注册管理办法（5-7）-EN
第五章 产品注册
Chapter V Product Registration
第三十一条 申请医疗器械注册，申请人应当按照相关要求向食品药品监督管理部门报送申报资料。
Article 31.To apply for medical device registration, the applicant shall submit application dossiers to the food and drug regulatory authority in accordance with relevant requirements.
第三十二条 食品药品监督管理部门收到申请后对申报资料进行形式审查，并根据下列情况分别作出处理：
Article 32.The food and drug regulatory authority shall conduct formal examination on the application dossiers after accepting an application, and handle respectively according to the following circumstances:
（一）申请事项属于本部门职权范围，申报资料齐全、符合形式审查要求的，予以受理；
(1)Where the application is within the scope of functions and duties of this authority, and the application dossiers are complete and meet the formal examination requirements.
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