澳大利医疗器械

TGA官方英文定义：
A medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including software necessary for its proper application) intended by the sponsor to be used for human beings for one or more of the following specific medical purposes:
(i) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability;

(iii) investigation, replacement, modification or support of the anatomy or a physiological or pathological process;

(iv) providing medical information by in vitro examination of specimens derived from the human body;

(v) control of conception;

and which does not achieve its principal 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，指由上市责任人（sponsor）拟用于人体、可单独或组合使用的任何仪器、装置、器具、软件、植入物、试剂、材料或其他物品（含实现其正常用途所需的配套软件），用于以下一项或多项特定医疗目的：
1. 疾病的诊断、预防、监测、预测、预后、治疗或缓解；

2. 损伤或残疾的诊断、监测、治疗、缓解或补偿；

3. 解剖结构、生理或病理过程的探查、替代、改造或支持；

4. 通过对人体样本进行体外检测，提供医疗相关信息；

5. 受孕控制（避孕）。

同时满足核心判定：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。