印度医疗器械

“medical device” means any instrument, apparatus, appliance, implant, material, in vitro diagnostic reagent, software or other article, whether used alone or in combination, including accessories, components or parts, intended by the manufacturer to be used for human beings or animals for one or more of the following purposes:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease, disorder, injury or disability;

(ii) investigation, replacement, modification, support or maintenance of anatomy or physiological process;

(iii) life support or life sustaining;

(iv) contraception;

(v) disinfection or sterilization of medical devices;

and which does not achieve its principal intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

医疗器械，指制造商拟单独或组合用于人体或动物的任何仪器、装置、器具、植入物、材料、体外诊断试剂、软件及其他物品（含附件、组件、零部件），用于以下一项或多项用途：
1. 疾病、紊乱、损伤或残疾的诊断、预防、监测、治疗或缓解；

2. 解剖结构或生理过程的探查、替代、改造、支持或维持；

3. 生命支持或维持生命；

4. 避孕；

5. 医疗器械的消毒或灭菌。

同时满足核心判定：产品主要预期作用并非通过人体或动物体内/体表的药理学、免疫学或代谢方式实现，此类方式仅可起辅助功能。