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30 Jun 2011 | Press Release

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Medical Device Senate Inquiry Supported By Dental Industry

Regulatory Affairs

The establishment of a Senate inquiry into the role of the Therapeutic Goods Administration (TGA) in regulating medical devices has been welcomed by the Australian Dental Industry Association (ADIA). ADIA is the industry body representing the manufacturers, importers and suppliers of dental product. According to ADIA, the establishment of the senate inquiry is timely given the many challenges that the TGA faces enforcing the medical device regulatory framework.

"On balance, ADIA supports the current regulatory framework administered by the TGA. That said, the Australian dental industry has observed areas for improvement, particularly in the area of regulatory enforcement," said Troy Williams, ADIA Executive Officer.

According to ADIA, the major challenge is associated with the importation of substandard dental product supplied outside the framework established by the Therapeutic Goods Act (Cth) 1989. In December 2010, the TGA decided to address this problem by adding further regulation, however ADIA does not believe this is the best approach.

"Additional legislation isn't the way to address the supply of noncompliant dental products. Additional regulations only result in an unwanted regulatory burden that results in higher costs that are invariably passed-on to patients. ADIA's preferred approach is for the TGA to step-up activities associated with the awareness of, and compliance with, current regulations governing the supply of dental product", Mr Williams said.

Initial proposals were for a Senate inquiry to review concerns associated with the regulation of hip implants. ADIA believed that a broader review was necessary and the Association communicated this need to a number of Senators.

"We are pleased that the Senate has responded to ADIA's representations with a wide-ranging inquiry into the role of the TGA's regulation of medical devices," Mr Williams said.

ADIA is currently preparing a submission on behalf of the dental industry which will be tendered to the Senate committee in the last week of July 2011.

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