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【单选题】
以下情形中,不属于医疗器械生产企业必须开展再评价的情形是( )。
A.
通过产品设计回顾性研究发现其医疗器械存在安全隐患的
B.
通过质量体系自查结果发现其医疗器械存在安全隐患的
C.
通过产前风险分析发现其医疗器械存在安全隐患的
D.
通过有关医疗器械安全风险研究文献获悉其医疗器械存在安全隐患的
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