Download eBS Medical Device User Manual

DEVICE APPLICATION
An Overview
The Device Application form is used to include a Medical Device or to
have an Other Therapeutic Good listed/registered on the Australian Register
of Therapeutic Goods (ARTG).
The form is made up of 12 pages of which you will only see a maximum of
Five (5). Some pages have slight variations (ie Page 1 has 2 variations and
Page 2A has 3 variations, 2B has 3 variations). The system will only
display the pages relevant to the type of Application being submitted.
Device Application (Medical Device – Other Classes) – Page 1
These notes relate to the above circled selections found in the drop down
list at Application For:
They are also relevant for :
Medical Device – Included
- Class 1 Measurement
- Class 1 Sterile
- Class IIa
- Class IIb
- Class III and
- AIMD
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