Call For Greater Dental Product Regulatory Enforcement

The industry body representing the manufacturers, importers and suppliers of dental product, the Australian Dental Industry Association (ADIA), is calling upon the Therapeutic Goods Administration (TGA) to step-up its regulatory enforcement activities. The call follows an item carried on the Channel 7 news program on 20 June 2011 addressing the safety aspects of materials used to manufacture false teeth and similar products.

"There is an emerging trend to source dental implants, crowns and similar custom-made dental products from off-shore dental laboratories. ADIA's interest is to ensure that these teeth are manufactured in accordance within the legislative framework administered by the TGA," said Troy Williams, ADIA Executive Officer.

Importers of dental product have a legal responsibility to ensure that all materials used in custom-made dental products comply with the Therapeutic Goods Act (Cth) 1989. According to ADIA, the increasing trend to source custom-made dental products from overseas reinforces the need for the TGA to increase awareness of, and compliance with, this legislation.

"ADIA has long-standing concerns with the regulatory enforcement activities of the TGA. There is a demonstrated need for the regulator to take a pro-active role in promoting the statutory responsibilities associated with sourcing dental product from overseas," Mr Williams said.

Acknowledging growing public concern associated with custom-made dental products, ADIA has written to the TGA asking them to review options to better regulate this product group.

"ADIA's priority is to work with the TGA to enhance an understanding of, and compliance with, the medical device regulatory framework, particularly as it applies to dental product. The ball is now in the TGA's court to develop a more comprehensive regulatory enforcement mechanism," Mr Williams said.