The Australian Dental Industry Association has given the thumbs up to the introduction of amendments to the Therapeutic Goods Act 1989 (Cth) that cut the red tape imposed by the Therapeutic Goods Administration (TGA) on local manufacturers looking to export—as well as businesses importing—innovative dental products from overseas.
“These reforms are the culmination of years of advocacy by ADIA and reduce the extent to which the compliance obligations placed on business by the TGA duplicate those of overseas regulators,” ADIA CEO Troy Williams said.
The revised legislation paves the way for organisations, other than the TGA, to assess products against design, performance and safety standards. This is expected to reduce compliance costs and reduce the time it takes to get new products to market.
“This is a great outcome for not only businesses in the dental industry, but also the entire medtech sector,” Williams said.
“Lower compliance costs and faster regulatory approvals create an environment in which local manufacturers can succeed.”
The legislation, passed by the parliament with bipartisan support, became law on 5 March 2018 upon receiving royal assent, and will allow the TGA to make better use of work conducted by comparable overseas regulators which will cut red tape for dental suppliers and manufacturers.
“The reforms provide a framework for the TGA to accept assessments conducted by Australian conformity assessment bodies other than the TGA itself. This will reduce the time required to bring new products to market,” Williams said.
The legislation also expands the investigation and enforcement powers of the TGA to more effectively deal with instances of illegal supply in the Australian market.
Based on a media release sourced from the ADIA website.