TGA, 关于定制医疗器械的新规定

澳大利亚医药品监管机构TGA（Therapeutic Goods Administration）发布了针对定制型医疗器械的新规定，相关规定于2021年2月25日开始正式使用。

 

新规定缩小了定制型医疗器械的范围，因此部分以前的产品可能无法满足定制医疗器械的标准。

这些医疗器械需在ARTG进行产品登记，相关部分可延期至2024年11月1日。

但若想进行延期，必须在2021年8月25日前提交下列表格:

 

 

NOTIFICATION FORM: Transition arrangements for custom-made medical devices - Australian Government Department of He

 

Descritption

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● introduce new definitions for personalised medical devices, thereby reducing the scope of the existing definition of a custom-made medical device;

● change the conditions of exemption for custom-made medical devices to:

- require annual reporting of custom-made devices supplied in the previous financial year;

- allow the TGA to inspect production facilities;

- require documentation about the device to be retained for 5 years (for non-implantable devices) or 15 years (for implantable devices); and

- require manufacturers to provide information about each custom-made medical device to the intended recipient.

 

 

Personalised medical devices (including 3D-printed devices)

 

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