SYDNEY, Australia: The Australian Dental Industry Association (ADIA) has advised the government panel currently reviewing medical device regulation in Australia to strengthen the regulatory framework for dental laboratory products. In particular, ADIA pointed out that there is a need for an obligatory statement of manufacture to be provided to patients and retained by dentists.
ADIA’s recommendations arose from the increasing prevalence of dental laboratory products sourced from overseas and the inability to readily identify the source of the products, the association stated.
While the regulatory standards for design, performance and manufacture of these devices are appropriate and do not require revision, ADIA believes that there is a need to consider revision of regulations governing the information provided to patients. It has thus called for a new regulation that will require companies that offer custom-made medical devices to provide a statement of manufacture in the future.
In order to identify unnecessary, duplicative or ineffective regulations that could be removed or streamlined without undermining the safety and quality of therapeutic goods available in Australia, the Australian government appointed a review panel in late 2014. According to ADIA, the review is 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 freeing industry from unnecessary regulatory burden.