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News

Ingeneus advocates change to the Therapeutic Goods Administration (TGA)

For Australian medical device manufacturers intending to supply in Australia, their only route to market relies solely on the TGA conformity assessment and subsequent inclusion on the Australian Register of Therapeutic Goods (ARTG).

The pathway to market to sell in Australia is significantly longer for local manufacturers compared to their overseas counterparts. Overseas manufacturers are able to prepare an Australian Declaration of Conformity using evidence from a third party notified body or the TGA. However, it is legislated that local manufacturers must solely rely on the TGA for Conformity Assessment Certification.

The crux of this issue is highlighted by the TGA’s reticence to provide timeline data for submissions and is further exemplified by the cognizance of EU notified bodies to client commercial deadlines.

In recent times, there has been industry groundswell for the introduction of third party conformity assessment for Australian manufacturers. Richard Walmsley CEO, raised this “elephant in the room” issue at the “The Modernisation of the TGA” AusMedtech session with Dr. Rohan Hammett, National Manager for the TGA. Interestingly, the TGA currently accepts overseas third party certifications for 97% of all conformity assessment reviews, however these services are currently denied to Australian manufacturers planning to supply in Australia.

Mr. Walmsley also advocates that mandatory timelines and application tracking be incorporated in TGA conformity assessment procedures so that local SMEs are not commercially disadvantaged by vacillating approval timelines. Although a hot issue in the industry, Dr. Hammett gave no indications that the TGA would be making any further announcements on the subject in the short term.

Image Below:

Richard Walmsley discussing third party conformity assessment with Dr. Rohan Hammett (TGA) at the recent AusMedtech 2011 Conference in Sydney

Picture Courtesy of Ray Messner Photography

1 - Ingeneus advocates change to the Therapeutic Goods Administration (TGA)