澳大利亚，TGA Essential Principals

TGA Essential Principals
TGA Regulation 2002

 

澳大利亚的医疗器械受TGA（Therapeutic Goods Administration）管制，需要在ARTG进行医疗器械注册。

另外，医疗器械应遵循TGA Regulation 2002的必要标准。

 

Essential Principals（必要标准）包含适用于所有机器的6项一般原则与适用于不同医疗器械的9项追加原则。

 

General Essential Principals – 6项

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·  use of medical devices not to compromise health and safety

·  design and construction of medical devices to conform to safety principles

·  medical devices to be suitable for intended purpose

·  long-term safety

·  medical devices not to be adversely affected by transport or storage

·  benefits of medical devices to outweigh any side effects.

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Design and construction Essential Principles – 9项

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·  chemical, physical and biological properties

·  infection and microbial contamination

·  construction and environmental properties

·  medical devices with a measuring function

·  protection against radiation

·  medical devices connected to or equipped with an energy source

·  information to be provided with medical devices

·  clinical evidence

·  principles applying to IVD medical devices only.

 

 

* 医疗器械的符合性评估是通过相关证据及程序持续检查和确认医疗器械是否遵守必要标准（Essential Principals）等程序，对安全/性能/获利/危险相关信息进行分析评价。

 

* 根据Risk Classfication的不同，符合性评估的程序与深度上也存在差异。

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