Offshore medical device testing 'will reduce red tape'

14 January, 2015

Outsourcing medical device safety testing to overseas regulators will reduce red tape for the domestic sector, according to the Australian Dental Industry Association (ADIA).

"ADIA member businesses supply more than ninety-five percent of the products used by dentists and allied oral healthcare professionals. These businesses are drowning in red tape and this review provides an opportunity to remove a lot of the unnecessary regulatory requirements," said Troy Williams, ADIA Chief Executive Officer.

Most dental products are deemed to be medical devices for regulatory purposes and thus fall within the purview of the Therapeutic Goods Administration (TGA). According to ADIA, the legislation administered by the TGA is long overdue for reform.

Risk management approach

"ADIA's key requirement is that the TGA's medical device regulatory framework be 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," Williams said.

The ADIA submission aligns strongly with a principle recently announced by the Australian Government that if a system, service or product has been approved under a trusted international standard or risk assessment, the 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.

"In a practical sense the pathway set forward by ADIA will allow Australian manufacturers and suppliers of dental products to rely upon certification of trusted overseas regulators, expediting the introduction of new and innovative medical technologies to the local market," Williams said.

Removal of low risk medical devices "step too far"

In its submission ADIA has also issued strong warnings on proposals to remove low risk medical devices from the Australian Register of Therapeutic Goods (ARTG). According to ADIA such a move will open the floodgates and see the use of substandard medical devices in homes and healthcare settings without effective regulatory oversight by the TGA.

"ADIA is a strong proponent of deregulation as is evidenced by the arguments set out in our submission to the review; however, the proposal to remove regulatory oversight of low risk medical devices is a step too far," Williams said.  

"If successful, this removal of regulatory oversight will compromise public health and safety. Such a move is as scary as it is ludicrous."

The ADIA's recommendations have been tendered to an expert panel appointed by the Australian Government to review medicines and medical device regulation.

The expert panel reviewing medicines and medical device regulation is to deliver its findings to the Australian Government by 31 March 2015.

Earlier this week the Consumers Health Forum raised doubts about the move, saying it would seriously erode Australia's capacity to make its own assessment of new medical devices.