Our "regulation week" comes to a close with a visit to Australia, where, after protracted consultations, negotiations, and rescheduling, the Australian IVD regulatory framework was updated back in July 2010.
After having been exempt from any form of pre-market assessment by the Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA), in vitro diagnostic devices must now be included in the TGA's Australian Register of Therapeutic Goods (ARTG).
Specifically, for devices that were already on the market before July 1, 2010, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG. Any IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied to the market.
If past experiences in Europe are any indication, device manufacturers won't get "serious" about the new regulation until much closer to the end of the transition period. Several good resources exist to help device companies navigate the new regulations:
- IVD Technoloy's article Regulation of IVDs in Australia provides a good overview for experienced regulatory professionals
- The changing regulatory environment of in vitro diagnostics [PDF link] is geared to readers with a more basic understanding of regulatory frameworks
- TGA maintains an informative web site; Regulatory framework for IVDs is a good starting point for exploration
- New year, new Spanish language rules
- Electronic labeling for medical devices comes to Canada
- Mexico recognizes devices, IVDs cleared by FDA, Health Canada
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