The Australian Dental Association Inc. (ADA) has yesterday advised patients to ensure that any custom-made dental prostheses and appliances are compliant with the Therapeutic Goods Administration’s requirements by asking their dentist to confirm the origin and regulatory approval status of any such prostheses or appliances.
Local suppliers to the dental industry have lobbied governments and the ADA for the last couple of years over the use of imported products and equipment which is available cheaply to the end-user because they avoid TGA scrutiny.
The ADA now says it has become aware of some reports which allege that dental prostheses or appliances made overseas and imported may be dangerous to the health of patients due to a lack of quality and safety in their production. ADA President, Dr Shane Fryer, said, “Dentists are required to ensure that custom-made dental prostheses or appliances made overseas comply with the Therapeutic Goods (Medical Devices) Regulations 2002 (TGR 2002) and are listed on the Australian Register of Therapeutic Goods (ARTG).
“The TGA has very strict guidelines on what can and cannot be imported. The ADA supports the TGA’s restrictions. It is illegal for any dentist to use imported dental prostheses or appliances if they do not comply with TGR 2002 and ARTG,” said Dr Fryer.
“The safety of patients is paramount to all dentists and the ADA.”
The importation of therapeutic goods is usually regulated by the TGA, which administers the ARTG and enforces the TGR 2002. Dentists must comply with both regulations if importing custom-made dental prostheses or appliances.
“If patients have any concerns, we ask them to double-check with their dentist that any materials are TGR 2002 compliant and registered on the ARTG”, Dr Fryer concluded.
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