Post-market Compliance

What Companies Must Still Manage After a Non-medical Determination

Consistency management after classification determination.

结果对应的是特定产品版本

分类界定结果基于正式提交的产品用途、结构、参数、附件和资料作出。后续变化如果影响产品定义,原结论不应被机械套用。

需要持续管理的内容

  • 产品型号、功能、参数、软件和配件变化
  • 中文说明书、标签和操作流程
  • 招商手册、培训课件和直播话术
  • 电商详情页和经销商宣传
  • 投诉、平台审核和监管问询记录
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.
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