Parliament’s Passing Of Medical Device Reforms Welcomed

1The peak business organisation representing manufacturers and suppliers of dental products, the Australian Dental Industry Association (ADIA), has welcomed the passage through parliament of legislation that will reduce the red-tape associated with the Therapeutic Goods Administration's (TGA) compliance obligations.

The reforms are contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 which was approved by the House of Representatives on 27 March 2017 and subsequently by the Senate on 14 June 2017.

"ADIA has been a strong proponent for these reforms that will reduce the costs associated with conformity assessment, the process of making sure medical devices meet TGA's standards for design and performance," said Troy Williams, ADIA Chief Executive Officer.

The change is to be achieved by amending the Therapeutic Goods Act (Cth) 1989 which will allow the Australian Government to designate third-party organisations (called Notified Bodies for regulatory purposes) in Australia to undertake conformity assessments. These new Notified Bodies will provide an alternative avenue, other than the TGA, for manufacturers of medical devices to obtain a conformity assessment certificate required before their medical devices may be included in the Register by the TGA.

"This is a significant reform that's long over-due and we congratulate the commitment of the Australian Government to making the changes necessary to reduce the complexity of obtaining market approval for new and innovative patient diagnostic and treatment options," Mr Williams said.

When the Australian Government announced an expert review of medicines and medical device regulation, ADIA used this as an opportunity to argue that reforms were required which would permit the TGA to rely upon the work of third-party Notified Bodies. ADIA continued to advocate for this as the Senate Community Affairs Committee undertook an inquiry into this legislation.

"ADIA believes that these reforms will streamline regulatory approvals of dental products without compromising their safety and quality. The passage of this legislation is therefore welcomed and a great outcome not only for ADIA member businesses, but also the broader medical technology sector," Mr Williams said.