TGA’s New Legislation To Cut Dental Industry Red Tape

By Australian Dental Industry Association, 8 March, 2018

The peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA), has welcomed the introduction of amendments to the Therapeutic Goods Act 1989 (Cth). The legislative reforms 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,” said Troy Williams, ADIA Chief Executive Officer.

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. Lower compliance costs and a faster regulatory approvals create an environment in which local manufacturers can succeed,” Mr Williams said.

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,” Mr 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.

“Until now, the TGA’s governing legislation has prevented it from appropriately addressing certain types of instances of illegal supply. These reforms give it the investigation and enforcement powers it needs to protect patients from illegally supplied dental products,” Mr Williams said.

ADIA supported the development and passage of these reforms through its contribution to a number of parliamentary inquiries over the past several years in addition to direct outreach with key Ministers.

“ADIA commends the Australian Government, and particularly the staff within the TGA, for their commitment to work with industry to implement these much-needed reforms. These reforms take Australia one step closer to a regulatory framework for medical devices ensures public health and safety, while at the same time freeing industry from an unnecessary regulatory burden, Mr Williams said.

Source: ADIA