加拿大医疗器械

法规原文：
medical device means an instrument, apparatus, contrivance, material, in vitro reagent, or other similar article, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in:
(a) the diagnosis, prevention, monitoring, treatment or mitigation of disease, disorder, abnormal physical state, injury or disability in human beings;

(b) restoring, correcting or modifying a body structure or a body function in human beings;

and that does not achieve its primary intended purpose through pharmacological, immunological or metabolic means within or on the human body.

It does not include any device intended for animal or veterinary use.

医疗器械，指仪器、器械、装置、材料、体外诊断试剂或其他类似物品（含其组件、零件、附件），其生产、销售或宣称用途为：
1. 诊断、预防、监测、治疗或缓解人体的疾病、紊乱、异常生理状态、损伤或残疾；

2. 修复、矫正或改变人体的结构或生理功能。

同时满足：核心预期用途并非通过人体内部/体表的药理学、免疫学或代谢方式实现；且不含任何动物或兽用用途的器械。

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