Medical device regulations

A Senate committee report that recommends an overhaul of regulations governing the importation of dental product has been endorsed by the Australian Dental Industry Association, the national body representing the manufacturers, importers, and suppliers of dental product.

According to ADIA, the recommendations from the Senate Community Affairs References Committee’s inquiry into the regulatory standards for the approval of medical devices in Australia will allow patients to have continued confidence in dental product. The committee’s report was tabled.

“Over recent years, ADIA has been lobbying to secure reforms to the medical device regulatory framework to ensure the continued availability of quality dental product in Australia," said Troy Williams, ADIA executive officer. "The Senate committee’s recommendations recognized that the importation of dental product is an area requiring reform, placing it firmly on the policy agenda.”

In a submission to the Senate committee, ADIA raised a number of issues relating to the regulations governing the supply of medical devices, primarily dealing with the importation of dental product via the internet. The committee’s report states that the unregulated importation of dental devices via the internet may indicate a much broader problem of inadequate regulation of other medical devices purchased through the internet.

The Senate committee is of the view that this requires further investigation and assessment by the Therapeutic Goods Administration.

“We endorse the Senate committee’s comment without reserve and look forward to working with the TGA to improve safeguards in this area,” Williams said.

The committee also noted that custom-made dental devices appear to escape TGA scrutiny. The Senate committee received advice that up to 50% of custom-made dental prostheses are manufactured overseas, with no validation at the source of manufacture.

“Senators should be congratulated for recognizing this as an area where reform is needed and again. ADIA looks forward to working with the TGA to improve patient safety,” Williams said.

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According to Williams, ADIA will work with the TGA to review the regulatory solution model suggested by the Senate committee, whereby patients are offered a statement of manufacture for the custom-made dental devices. Practitioners are obliged to retain this statement for the lifetime of the prosthesis, and must record whether the statement was provided to the patient or not.

“The Senate committee has noted the lack of effective regulation associated with the importation of medical devices by individuals is very concerning and should be addressed as a matter of urgency," Williams said. "ADIA supports this inclusion entirely.”

For more information, go to www.adia.org.au.

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