Trudy
For medical devices/IVDs:
The great majority of Australian medical device product registrations are done based on existing CE certificates. TGA only mandates direct Australian conformity assessment for CLass III devices containing a medicine or biological origin material. Terefor by default these are the devices for which TGA do most inspections. They also have a relatively small inspectorate so tend to take into account existing international certifications (especially CE and ISO 13485) and use these as evidence to justify to postponement of inspections in many cases. TGA is also very keen to leverage the MDSAP program to avoid need for their direct inspections.
With regard IVDs there is much more direct TGA assessment - as the Australian classification system requires far more IVDs to be assessed (although this will change as Europe implements new regulations with a classification system much closer to that already used in AUstralai (and in Canada). Again TGA is likley to focus on Class IV IVDs - essentially HepC, HIV and blood typing - i.e. IVDs with high public health risk.
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Arthur Brandwood PhD FRAPS
Brandwood Biomedical Pty Ltd
St Leonards
Australia
Original Message:
Sent: 05-Jun-2016 17:14
From: Trudie Seeger
Subject: Health Canada and TGA Inspections
I am looking for regulatory intelligence on Health Canada and TGA Inspections of manufacturing facilities both for medical devices/IVDD and for APIs. Is anyone familiar with these inspections, what areas they are focusing on and what are their current concerns.
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Trudie Seeger
Columbus OH
United States
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