体外诊断试剂说明书的变化是否均需申请许可事项变更？
体外诊断试剂产品说明书的内容变化包括两种情况：信息性内容的文字性变化和其他内容变化。
（一）信息性内容的文字性变化
依据《总局办公厅关于体外诊断试剂说明书文字性变更有关问题的通知》（食药监办械管〔2016〕117号），信息性内容的文字性变化可由申请人自行修改。
具体内容包括：
【基本信息】项目中体外诊断试剂的注册人或者生产企业联系方式、售后服务单位名称及联系方式、生产许可证编号或者生产备案凭证编号的变化、进口体外诊断试剂代理人联系方式的变化。其中，生产许可证编号或者生产备案凭证编号应在相应省级食品药品监督管理部门发放生产许可证或者生产备案凭证后再行修改。
【医疗器械注册证编号/产品技术要求编号】项目，在相应食品药品监督管理部门发放医疗器械注册证后，导致该项内容变化的情况，注册人应自行修改。
【标识的解释】项目，因注册人按照YY/T 0466系列标准完善体外诊断试剂说明书中相应标识的解释内容，导致该项内容变化，但不涉及其他需办理许可事项变更的情况，注册人应自行修改。
【主要组成成分】中列明，必须配套使用的医疗器械或体外诊断试剂，由于相应食品药品监督管理部门发放医疗器械注册证/备案凭证后，导致说明书中载明的配套使用的医疗器械或体外诊断试剂注册证编号/备案凭证编号发生变化的情况，注册人应自行修改。
（二）其他内容变化
作为注册证附件，体外诊断试剂说明书的内容应视为注册证载明内容，除上述信息性内容外，其他内容变化应通过许可事项变更申请进行修改。
说明书更改告知不适用于体外诊断试剂。
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