Medical Device Review Gets Tick From Dental Industry

The report from a comprehensive independent review of medical device regulation has received support from the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products. 

“The report’s recommendations identify opportunities to enhance the regulatory frameworks for medical devices by continuing to harmonise the Australian regulatory system with international regulatory frameworks.  This is great news for Australian manufacturers of dental products and will allow them to grow, create jobs and operate sustainably,” said Troy Williams, ADIA Chief Executive Officer.

The report, released earlier this week, is one of the most comprehensive into medicines and medical devices regulation.  Undertaken by an independent expert panel and tendered to the Minister for Health, the report makes high level recommendations on the regulatory frameworks for medicines and medical devices, as well as on access to unapproved therapeutic goods in special circumstances.

“This report has a strong focus on accelerating entry to the Australian market for new medical technologies.  ADIA welcomes recommendations that seek to expand the pathways by which business can seek marketing approval for a medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in certain circumstances,” Mr Williams said.

ADIA had been concerned that the report may seek to remove the requirement to place low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG), the list of therapeutic goods that can be lawfully supplied.  ADIA had strongly argued against taking low-risk medical devices off the ARTG in is submission to the review panel and in follow-up discussions.  With respect to this issue, the report has recommended that the Australian Government undertake a review of the range of products currently classified as Class 1 medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions.

“The report recognises the dental industry’s view that low-risk medical devices remain on the ARTG as their inclusion provides a number of benefits, such as prompting manufacturers to consider their legal responsibilities to comply with manufacturing, quality, performance and safety standards.  Further, there is recognition that the inclusion of low-risk medical devices on the ARTG facilitates post-market monitoring as there is a record of the device and the sponsor,” Mr Williams said.

ADIA commences the process of working with the Australian Government to frame the latter’s response to the report, with the first meeting of ADIA member businesses to discuss this matter being held this week.