The focus on acceptance of international standards as part of the Industry Innovation and Competitiveness Agenda will support local producers of dental products according to the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of quality dental products.
"ADIA fully endorses the Australian Government's adoption of the principle that if a product has been approved under a trusted international standard or risk assessment, then Australian regulators should not impose additional requirements for approval in Australia unless there is a reason to do so," said Troy Williams, ADIA Chief Executive Officer.
In a significant move for the Australian dental industry the Prime Minister, the Hon. Tony Abbott MP, has announced that Australian manufacturers of medical devices (the description of most dental products for regulatory purposes) will have the option of using European Union certification rather than certification by the Therapeutic Goods Administration (TGA).
"This is arguably the most significant reform to medical device regulation in more than a decade. It greatly reduces the regulatory burden for domestic manufacturers and helps level the playing field, strengthening their ability to compete internationally," Mr Williams said.
ADIA has been actively working at a parliamentary level to ensure that the regulatory framework for medical devices is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from an unnecessary regulatory burden. According to Mr Williams, the reforms set out in the Industry Innovation and Competitiveness Agenda are an important step in the right direction.
"For far too long, Australian manufacturers of dental products have had to submit themselves to TGA approval processes that replicate those already undertaken overseas. Today's announcement that this will no longer be the case is what cutting red-tape is all about and will deliver real benefits for Australia's dental industry," Mr Williams said.
As recently as last week ADIA met with the Assistant Minister for Health, Sen. Hon. Fiona Nash, to highlight the need for reform in this area, advocacy that has been supported by ADIA's discussions with the Parliamentary Secretary to the Prime Minister, the Hon. Josh Frydenberg MP, who has responsibility for the Australian Government's deregulatory agenda.
"The leadership shown by the Assistant Minister for Health and the Parliamentary Secretary in pushing for this important reform is acknowledged by ADIA," Mr Williams concluded.
Friday, 6 December, 2024