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Bio Technology : July 2009
AusMedTECH Classification and conformity assessment arrangements will broadly mirror the European IVDD requirements, although the classification arrangements have some significant differences in the detail. Most notably the TGA proposes a complete ban on home-use tests for serious disorders such as cancers or myocardial infarction, serious infectious diseases or genetic tests. TGA/NATA joint oversight of in-house tests Currently all in-house tests conducted entirely within a laboratory or lab network are outside of the scope of TGA regulation. Under the new arrangements, laboratories manufacturing in-house tests will be required to register the types of IVDs on a new TGA IVD database. Such laboratories will be required to hold NATA accreditation, with demonstrated compliance with the suite of standards on the validation of in-house IVDs, as published by the National Pathology Accreditation Advisory Committee (NPAAC), for each in-house test manufactured. Only the highest risk (Class 4) tests will be directly assessed by TGA. It’s a significant ‘kind of’ change – and what about third party assessment? Key questions remain about the implementation with particular uncertainty about grouping of devices in the ARTG, and role of third party assessors. The approach embodied within medical device regulation of a single ARTG entry covering a range of devices of one kind is likely to present some particular challenges. It may be possible to have tests for the same purpose but using quite different methods all included within the one ARTG entry. The key is that if a new test method is introduced after the conformity assessment has been conducted, then this would be considered a significant change, which requires the manufacturer to notify their Conformity Assessment Body and submit to an additional review of the change. Policing that particular requirement, especially for imported devices promises to be a particular challenge that is making the TGA think again about how ARTG entries are to be structured for IVDs. The TGA has learned from the implementation of transitional arrangements from the introduction of the devices regulations. Annual charges will not apply until the close of the transition period. TGA hopes that this will encourage sponsors to transition early in the four-year transition period, hopefully avoiding the last minute rush. Volume 19 • Number 2 • July 2009 Australasian BioTechnology 35 This change is set against the background of current consultation regarding implementation of third party conformity assessment in Australia. The current proposal for the TGA keeps the requirement for direct TGA conformity assessment of Australian manufacturers of IVDs. All of this is presenting significant challenges to the TGA, both in getting the structure of the regulations right and in finding the resources to take on a very substantial additional workload. It remains to be seen if the end of year target can be met. Arthur Brandwood is Managing Director of the regulatory advisory firm, Brandwood Biomedical and an adviser to the AusMedtech National Board and represents AusBiotech in consultations with government. More discussion of the upcoming TGA regulations, including a detailed look at the proposed classification scheme can be found at www.brandwoodblog.com.au