行业认证
Medical Device Registration Specialist (Registration Submission)
医疗器械注册专员（注册申报）
考核医疗器械注册法规、申报资料编写与流程管理，适合注册与法规事务人员。
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A sample question · with answer and explanation
境内第二类医疗器械注册申请受理后，技术审评过程中需要补正资料的，注册申请人应当在多长时间内按照补正通知的要求一次性提交补充资料
AI explanation知识点为注册审评补正资料时限。正确项对：法规规定申请人应在收到补正通知之日起1年内提交补充资料。错项：6个月和3个月均短于法定期限，属于把其他行政程序时限张冠李戴；60个工作日同样无此规定，是把工作日与自然日概念混用。
About the Medical Device Registration Specialist (Registration Submission) exam
- Issuing body行业协会或第三方培训机构
- Choose your level不分级
- Question bank300 questions online (growing)
- Practice modesSequential practice, mock exam, flash review, mistake drills
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