泰国医疗器械

Medical Device means any instrument, apparatus, utensil, machine, equipment, implant, material, software, in vitro diagnostic reagent or other article, intended by the manufacturer to be used alone or in combination, for human beings for one or more of the following medical purposes:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation or compensation for injury or disability;
investigation, replacement, modification or support of the anatomy or physiological process;
life support or sustaining life;
control of conception;
disinfection or sterilization of medical devices;
providing medical information through in vitro examination of human specimens;
and which does not achieve its primary intended action in or on the human 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的任何仪器、器械、器具、设备、植入物、材料、软件、体外诊断试剂及其他物品，用于以下一项或多项医疗用途：
疾病的诊断、预防、监测、治疗或缓解；
损伤或残疾的诊断、监测、治疗、缓解或补偿；
解剖结构或生理过程的探查、替代、改造或支持；
生命支持与维持；
受孕控制（避孕）；
医疗器械的消毒或灭菌；
通过人体样本体外检测提供医疗信息。
同时满足核心判定要件：
产品主要预期作用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。