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第十条对于体外诊断试剂产品,增加装量差异的包装规格(仅装量差异)、增加相同自动化程度适用机型的许可事项变更,可免于提交分析性能评估资料、产品变化相关风险分析资料、产品技术要求、产品说明书、标签样稿。注册审评时限缩短至30个工作日。企业在严格执行质量体系要求的基础上,完成相关风险分析、性能评估、设计更改等工作,保存记录,以待后续检查备查。条款解读:仅限申报上述两项许可事项变更的一项或两项,如合并其他许可事项变更不适用本条款。企业应提交相关说明。第十一条对于未在有效期满前6个月申请注册延续的按照首次注册办理,如产品无变化,可提交最近一次注册临床资料、注
Article 10 For the in vitro diagnostic reagent products, increasing the packaging specifications (loading difference only) for adding different quantities and adding the changes of the permitted items for the same automation degree may be exempted from submitting the analytical performance evaluation data, product change related risk analysis data , Product technical requirements, product manuals, label samples. Registration review time limit shortened to 30 working days. Enterprises in the strict implementation of quality system requirements based on the completion of the relevant risk analysis, performance evaluation, design changes and other work, save the record for further inspection for future reference. Interpretation of articles: only to declare the changes of the two permits one or two, such as changes in merger of other permits do not apply the terms. Enterprises should submit the relevant instructions. Article XI for not valid for 6 months before the expiry of the application for renewal of the registration for the first time, if there is no change in the product, you can submit the latest registration of clinical information, note