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09 Jun 2017 | Press Release

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TGA’s Initiative Explain 1,069 Pages Of Legislation Welcomed

Regulatory Affairs TGA

The peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA), has welcomed the launch of the SME Assist initiative by the Therapeutic Goods Administration (TGA). It's a stance taken by ADIA because businesses in the dental industry find the medical device regulatory framework complex and verging on indecipherable.

The SME Assist initiative will support healthcare innovation and small business. The initiative will see the TGA provide free resources such as assistance with building a support network and information about regulators and funding opportunities.

"ADIA has been a strong advocate for reforms that make the TGA's regulatory framework less complex and easier to navigate for business. The SME Assist initiative is one outcome of ADIA's advocacy in this area," said Troy Williams, ADIA Chief Executive Officer.

Small businesses in the dental industry are confronted with some 1,069 pages of legislation that the TGA uses regulate the manufacturing and supply of dental products. Small business have often found navigating their way through this a challenge when seeking to introduce new and innovative dental products to the Australian market.

"ADIA congratulates the commitment of the Australian Government to assisting these businesses better understand the most efficient way to secure market approval for new and innovative patient treatment options," Mr Williams said.

There are eight industry associations in the therapeutic goods sector and it's the ADIA membership that stand to benefit most from the SME Assist initiative.

"ADIA has the largest corporate membership of the industry associations in the therapeutic goods sector and the largest SME membership. Indeed, more than three-quarters of our membership has an annual turnover of less than ten million dollars. That's what makes this announcement so meaningful for ADIA member businesses," Mr Williams said.

The SME Assist is one of a number of reforms by the TGA instituted during the course of the past year that align with ADIA's advocacy priorities.

"Our message to government has been clear. In order to grow, create jobs and operate sustainably we need the TGA to be more responsive to the needs of the SME sector. Today was a great step forward in this area," Mr Williams concluded.

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