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18 Sep 2012 | Press Release

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Senate committee confirms standards for imported dental lab products

Regulatory Affairs TGA Offshore 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 released last week.

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.

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

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