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  • 1.  Technical File for Australia/TGA

    This message was posted by a user wishing to remain anonymous
    Posted 31-Jan-2019 15:04
    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!



  • 2.  RE: Technical File for Australia/TGA

    Posted 01-Feb-2019 04:06
    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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  • 3.  RE: Technical File for Australia/TGA

    This message was posted by a user wishing to remain anonymous
    Posted 01-Feb-2019 10:14
    This message was posted by a user wishing to remain anonymous

    Do you know whether the Part A, Part B type of format for CE marking will be acceptable by Australia TGA?


  • 4.  RE: Technical File for Australia/TGA

    Posted 02-Feb-2019 10:27
    I personally would not use Part A and Part B format ... that is really old now (not state of the art).  Either use STED or even the recently published IMDRF RPS (Regulated Product Submission) format.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 5.  RE: Technical File for Australia/TGA

    Posted 06-Feb-2019 17:53
    ​I agree with Richard, however, TGA does not mandate a format for techincal file. So both your and Richard's advice is acceptable. Please be advised that TGA will not review your technical file for class I (non-sterile devices).

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    Romit Singh
    Pre Market Team Leader
    Belrose
    Australia
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