Hello Katarzyna,
First want to clarify discussions with your Notified Body should only relate to distribution in the European Union not for distribution in Australia. Your Notified Body (assuming you are not using TGA as your Notified Body) does not have jurisdiction over Australian regulatory requirements or distribution in Australia entails. They may say because it is CE Marked, blah blah, but CE Mark is just a least burdensome pathway to regulatory approval in Australia - it is not required for distribution in Australia - what is required is ARTG listing and registration. When you speak about TGA, this is applicable to products being distributed in Australia.
If you look at guidance like Australian Regulatory Guidelines version 1.1 (ARGMD) there is information about record retention (note TGA is updating the ARGMD because they have had many subsequent regulations and guidance published, in addition they are updating their regulations to reflect changes in Europe as well). 'In Australia, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. However, distribution records relating to Class AIMD, Class III or implantable Class IIb medical devices must be retained by the sponsor for inspection by the TGA for 10 years.' Again this only applies to distribution in Australia. The challenge is many of the regulations from Australia are similar or based upon the European regulations - in fact they have a note in the guideline about record retention of implants in Europe being 15 years, not 10 years.
My recommendation is clarifying with your Notified Body which regulation they are citing and which one they are enforcing. Because obviously a Notified Body can not and should not enforce requirements in Australia for TGA.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-Mar-2021 17:11
From: Katarzyna Chrusciel
Subject: Australia Quality Agreement
Good evening everyone,
I have one question. Can someone confirm that the records retention of 5 years is acceptable for manufacturer European from Regulatory point of view if the distributor is from Australia and for the same type of devices have to keep all the records 5 years according to TGA?
I had some discussion with notified body and I will be very happy to hear your opinion.
Thank you in advance
K
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Katarzyna Chrusciel
Engineer
Cavezzo
Italy
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