巴基斯坦医疗器械

Medical Device means any instrument, apparatus, utensil, machine, including operating software, implantable material, diagnostic agent, material, substance or similar article, intended to be used alone or in combination, directly or indirectly, for human beings for one or more of the following purposes:

- diagnosis, prevention, surveillance, monitoring or assistance in the treatment of disease;

- diagnosis, surveillance, monitoring, treatment, protection, absorption, drainage or assistance in healing of injury;

- substitution, modification or support of anatomy or physiological process;

- life support;

- control of conception;

- disinfection or sterilization of medical devices;

- provision of medical information via in vitro examination of human specimens;

- use in in vitro fertilization and assisted reproduction;

- incorporation of human or animal tissue materials.

It does not achieve its primary intended effect by pharmacological, immunological or metabolic means within or on the human body, but may be assisted by such means.

医疗器械，指可单独或组合、直接或间接用于人体的任何仪器、器械、器具、设备（含配套操作软件）、植入材料、诊断试剂、物料、物质及同类物品，用于以下一项或多项医疗用途：

1. 疾病的诊断、预防、监测、监护或辅助治疗；

2. 损伤的诊断、监测、治疗、防护、吸收、引流或辅助愈合；

3. 解剖结构或生理过程的替代、改造或支持；

4. 生命支持；

5. 受孕控制（避孕）；

6. 医疗器械的消毒与灭菌；

7. 通过人体样本体外检测提供医疗信息；

8. 体外受精与辅助生殖；

9. 含人体/动物组织材料的医用制品。

同时满足核心判定：产品主要预期效果并非通过人体内部或体表的药理学、免疫学或代谢方式实现，此类方式仅可起辅助功能。