Question about Australia - TGA and MDSAP - Technical file



Hi everyone

Thanks for all your help so far. A company has not started marketing in Australia and has no regulatory approvals at all in Australia. There is also no technical file. To satisfy the MDSAP requirements for Australia, in addition to meeting the QMS requirements, what other regulatory requirements are looked at during the audit for Australia? I read in the companion document that there will be a review of technical file for compliance with Essential principles. If the company has never entered Australia or EU, how are they going to update the technical documentation for compliance with Essential Principles before the MDSAP audit?

Thank you very much.


If a company is not active in Australia (or in any other of the 5 MDSAP countries), it will not be inspected in a MDSAP audit. Usually in the audit plan the MDSAP countries, in which the company is active, have to be selected, and only the requirements of the selected countries will be checked.


Involved In Discussions
The TGA has good guidelines on the TGA website for manufacturers. The most important thing is to classify the product and then, create a Technical file in STED format (See also GHTF guidelines, now IMRDF).
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Practically speaking, your Sponsor should be very willing and able to help you with this as they are bearing the front-line risk.
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