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Bio Technology : July 2009
AusMedTECH New Australian IVD regulations by year’s end? By Arthur Brandwood, Brandwood Biomedical Pty Ltd AusBiotech has several fora in which industry issues are discussed with the TGA. These include a CEO forum, the Industry Consultative Committee, the Technical and Regulatory Committee, the Medical Devices Technical Experts Reference Group, and other ad hoc opportunities. The TGA has published its plans for the long-awaited new regulatory framework for in vitro diagnostic devices (IVDs). The system will use a conformity assessment model closely aligned with the European/GHTF systems, with risk-based classifications determining the level of regulatory review. The TGA plans an end of 2009 implementation date with a four-year transition period before the new framework becomes mandatory. In theory, this is a relatively simple change in regulations only, with no need to change the Therapeutic Goods Act. However, the ‘devil’ is always in the detail and it remains to be seen if this target will be met. As part of delivering on some of the reforms embodied within the now lapsed Trans Tasman ANZTPA agency, the TGA plans to implement a full regulatory framework for IVDs, which will be brought within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002. As there is no change to the primary legislation in the Therapeutic Goods Act, the new regulations only require to be tabled in Parliament, with no requirement to introduce or debate a new bill. Exemptions to end – and some home tests to be banned Most IVDs are currently exempt from TGA review although post-market regulations still apply. Current regulation only covers a few IVDs, most notably HIV and HCV tests, and home-use kits. The new regulations will capture all IVDs with a human therapeutic purpose, with application fees of $760 per device and conformity assessment fees starting at around $6,000 and rising to $49,000 for design dossier reviews of high-risk Class 4 IVDs. Non-therapeutic IVDs (e.g. parentage and kinship tests, sports drug tests, tests for detection of alcohol or illicit drugs and veterinary IVDs) will not be included within the new regulations. 34 Australasian BioTechnology Volume 19 • Number 2 • July 2009