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31 Jul 2012 | eLABORATE

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Senate committee confirms standards for imported dental lab products

Regulatory Affairs TGA Offshore Lab Work

Ensuring the Australian public enjoys the same protection in regard to product safety when having a crown placed in their mouth as any other "medical device" continues to be a goal many agencies in the dental community and related areas strive towards.


In a positive move towards greater regulation of imported dental lab work, the Australian Government has confirmed that dentists and resellers of imported dental laboratory work are subject to the same statutory obligations as local laboratories.

The advice is contained in the Australian Government's response to a Senate committee inquiry into the regulatory standards for medical devices.

The peak representative body for suppliers of quality dental products, the Australian Dental Industry Association (ADIA), tendered advice to the Senate committee. The findings of the committee were that the Therapeutic Goods Administration (TGA) should subject imported laboratory work to the same regulatory standards as locally produced products.

"ADIA sought to create a level playing field for local suppliers and to a large extent this is the outcome," said Troy Williams, ADIA Chief Executive Officer.

The Australian Government's response stated that importers of dental laboratory work must hold certain details about the device including information identifying the manufacturer and any special characteristics of the device.

"The Government's response has confirmed that dentists and resellers of laboratory work still have the option of using imported goods. However, the Government has clearly stated that imported products, like locally manufactured products, are subject to Australian regulatory standards," Mr Williams said.

An importer of laboratory work does not need to place such products on the Australian Register of Therapeutic Goods (ARTG). However, importers do need to comply with all other aspects of the Therapeutic Goods Act (Cth) 1989 relating to medical devices. This includes being able to demonstrate that the device complies with regulatory standards governing the safety of materials that are used, and that the product can be used safely with any material or substance with which the device may come into contact during normal use.

ADA supports initatives

The Australian Dental Association (ADA) has also expressed its support for a tightening of regulations regarding imported laboratory work as the practice is now so widespread that greater controls are overdue.

"The TGA has very strict guidelines on what can and cannot be imported," said ADA Federal President Dr F. Shane Fryer. "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 the overall TGA framework.

"The safety of patients is paramount to all dentists and the ADA. If patients have any concerns, we ask them to double-check with their dentist that any materials are TGR 2002 compliant and on the ARTG."

To raise awareness amongst dental professionals, the Australian Government will consult with the Dental Board of Australia (DBA).

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