IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on 1 July 2010. These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs). The greatest implications of which include IVD classification based on risk and the first regulatory implementation of GHTF IVD Guidance.

To this end, the new classification of IVDs has been transposed from the GHTF to consist of Classes 1, 2, 3, and 4 in increasing order of risk. Further, the new regulations require that all IVDs be registered in the Australian Register of Therapeutic Goods (ARTG) prior to sale after 1 July 2010. Those products which are currently on the market and not in the ARTG, (as they were previously considered unregulated) will have until 2014 to do so; thus providing a four year transition period. For these products eligible for the four year transition period, it is our understanding (based on communication with the TGA) that documents proving that the product had been sold or advertised prior to 1 July 2010 may constitute evidence of supply. The 1 July 2010 implementation date applies only to IVDs that are new to the market.

You can download a PDF copy of the Therapeutic Goods Amendment Regulations 2010 (amends the overarching Therapeutic Goods Regulations 1990) and a PDF copy of the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (amends the specific Therapeutic Goods (Medical Devices) Regulations 2002. Additionally, see our article on the Australia IVD regulation for further details including those on conformity assessment, Technical File Review (TFR) (for many Class III IVDs as well as point-of-care IVDs and self-test IVDs, for which TFR will be compulsory).

ARGMD Guidance Issued

Previously, we mentioned the TGA guidance as a draft, but recently, new extensive guidance (ARGMD Version 1.0 April 2010) was officially published to the TGA website in May, despite its April date. The ARGMD guidance provides thorough information for manufacturers and sponsors navigating the TGA regulatory process. The ARGMD is a veritable tome of guidance, and though it was developed for Australia, the guidance, with explicit details on meeting Essential Principles and Conformity Assessment, for example, may be useful for the EU as well. The structure of the guidance is explored below. The full text of the newly released ARGMD Guidance can also be found in the Australia section of our Learning Library.

The ARGMD guidance is composed of three overarching sections: Introduction, Pre-Market, and Post-Market. Part 1, Introduction, contains details on the guidance itself, fees and charges for medical devices, essential principles, classification of medical devices, conformity assessment overview, what manufacturers and sponsors need to know about conformity assessment, differences between the Australian and EU medical device requirements, and international agreements. Guidance on how to include devices in the ARTG, how to prepare for application audits, as well as general information on different types of medical devices (e.g. active, those which contain a medicine or materials of animal, microbial, or are of recombinant origin, etc.) are delineated in Part 2, Pre-Market. Finally, Part 3, Post-Market, explicitly covers changes to ARTG Inclusions, post-market vigilance and monitoring requirements, and recalls, suspensions, cancellations and tampering of medical devices.

Change of Australian Sponsor Process Simplified

Also of newsworthy importance, the new amendment to the Therapeutic Goods Regulations 1990 has simplified the transfer of Australian Sponsor process. The original sponsor must complete a form to transfer the sponsorship of an ARTG entry- relinquishing company; and the new sponsor must complete the form to transfer sponsorship of ARTG Inclusions for medical devices – accepting company. Once an ARTG listing number exists, the process to transfer sponsorship is easy:

• The two forms described above must be completed;
• A third form needs to be completed by the accepting (new) sponsor;
• Payment of transfer fees (see current list of fees and charges here); and,
• Annual fees must be paid before the entries can be transferred.