Medical Device Regulatory Review Welcomed By Dental Industry

The Australian Government's review into medical device regulation has been welcomed by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products. The review is of strategic importance to the dental sector as many of the products used in dentistry are deemed to be medical devices for regulatory purposes.

"ADIA sees this review as an important step in securing a regulatory framework for medical devices that is based upon a risk management approach designed to ensure public health and safety, while at the same time freeing industry from an unnecessary regulatory burden," said Troy Williams, ADIA Chief Executive Officer.

According to Mr Williams, this review of medical device regulation provides an excellent opportunity to advance recently announced Australian Government reforms that are based upon the principle that if a product has been approved under a trusted international standard or risk assessment, then the Therapeutic Goods Administration (TGA) should not impose any additional requirements for approval in Australia, unless it can be demonstrated that there is a good reason to do so.

"ADIA has been a strong advocate for reforms that will reduce the excessive red-tape that prevails across the medical device sector. The practical outcome for the dental industry is that much of the product testing and certification done overseas in a trusted jurisdiction is replicated, increasing costs and creating delays in introducing new products to market," Mr Williams said.

The review will identify areas of unnecessary, duplicative or ineffective regulation that could be removed or streamlined without undermining the safety of quality of therapeutic goods available in Australia.

The major policy priority for ADIA is to create a regulatory framework for the approval of medical devices that allows businesses across the dental industry to grow, create jobs and operate sustainably," Mr Williams said.

The Australian Government announcement advised that the review will be lead by Emeritus Professor Lloyd Sansom AO who will be assist by Mr Will Delaat AM and Professor John Horvath AO. Mr Williams said ADIA looks forward to working with the members of the review team to ensure unnecessary regulatory duplication for medical devices is eliminated.