Recommend using the Standard Technical Document or STED format (as defined by the GHTF/IMDRF guidance document) as this has been recognised by Australia TGA for quite some time. They are essentially the same format as you would use for European Union CE Marking; using the STED format is recognised by a few regulatory agencies around the world and is a good way to compile technical information related to the product. Just keep in mind the STED format is a nice structure or outline, but the actual compilation of technical documentation should reflect the current regulatory status of the product.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-Jan-2019 11:15
From: Anonymous Member
Subject: Technical File for Australia/TGA
This message was posted by a user wishing to remain anonymous
Hello Australian colleagues,
With the EU transiting into MDR, I'm looking at registering a Class I (non-sterile, non-measuring) device in Australia prior to CE mark. Can anyone comment on what is required for Australian Technical File in addition to the Essential Principles checklist and Australian DoC? How similar is it to the Tech File for obtaining CE Mark of a Class I device?
Thank you!