MDC: Outcome: Class i (9)

Based on your selections, the classification of your device is Class I.

About Class I

Devices of this classification are low-risk. 

They do not require conformity assessment certification before they can be included in the Australian Register of Therapeutic Goods (ARTG). 

They are included in the ARTG on the manufacturer's declaration that the devices comply with the relevant essential principles for safety and performance.

More information

• Medical device regulation basics
• Australian Regulatory Guidelines for Medical Devices (ARGMD)

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