Issue No. 39
Australia Implements New IVD Regulatory Framework
Following a seven year period of negotiation with the medical device industry, the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (the MD Amendment Regulations) and the Therapeutic Goods Amendment Regulations 2010 (the TG Amendment Regulations) were approved by Australia's Governor-General. The MD Amendment Regulations will implement a new regulatory framework for in vitro diagnostic (IVD) medical devices under the Therapeutic Goods Act 1989 and provide for a four-year transition period. The TG Amendment Regulations will enforce significant amendments that reflect changes in the regulatory framework as they apply to IVDs. The regulations come into force on July 1st, 2010.(1)
The primary purpose of these regulations, more commonly referred to as the "IVD Regulatory Framework", is to provide a mechanism for the regulation of all IVDs sold in Australia. Historically, only a limited range of IVDs have required premarket regulatory approval and inclusion in the Australian Register of Therapeutic Goods (ARTG). The new framework requires all new IVDs to be listed on ARTG prior to distribution.
The IVD framework was conceived in 2003 by the Therapeutic Goods Administration (TGA) in conjunction with the medical device industry. The proposed framework was originally envisioned to complement the revised medical device regulations introduced in 2002. Negotiations between the Australian Health Minister's Conference and industry stakeholders which began in 2003 were expected to be followed by a TGA draft containing changes to the medical device regulations. However, the failed implementation of the Australian and New Zealand Therapeutic Products Authority severely derailed this process and negotiations did not recommence until early 2009.
The framework harmonizes Australia's IVD regulations with those recommended by the Global Harmonization Task Force (GHTF). Following the model laid down by the GHTF, Australian IVDs will be classified into four classes based on assessed personal and public health risk. The highest risk products will be included in Class 4 and progressively lower risk products in Classes 3, 2 and 1. Manufacturers will be required to assign their products into a particular risk class based on a series of classification rules outlined in the regulations. Several products will remain exempt from the regulatory requirements. These include products used solely for workplace or home drugs of abuse and alcohol testing; genetic tests to determine parentage or relationship; and IVDs used exclusively for veterinary purposes.(2)
While industry is largely supportive of the IVD regulatory framework, it continues to have concerns regarding how the changes will impact manufacturers and sponsors. A key consideration for industry is the potentially significant increase in regulatory expenditures. TGA estimated the cost over the first five years would be roughly $16 million dollars while IVD Australia, the association representing Australian IVD manufacturers and suppliers, believes it more likely that the direct cost to sponsors and manufacturers will actually exceed $25 million.(3) Industry is also apprehensive that these costs may result in sponsors reevaluating the importation of selected products and that several older but important diagnostic tests may not be transitioned into the new framework.
IVD Medical Devices Regulations
New IVD Legislation
Release of In Vitro Diagnostic Regulations
Therapeutic Goods Amendment Regulations 2010 (No. 1)
Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No.1)
(1) IVD Medical Devices Regulations
(2) Release of In Vitro Diagnostic Regulations
If you desire further information about this topic or any other regulatory issue, please feel free to contact me:
Diane R. Whitworth
DRW Research & Information Services, LLC
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