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TGA Encourages Reporting of Non-compliant Dental Devices

TGA Encourages Reporting of Non-compliant Dental Devices

7th Jun 19

The Therapeutic Goods Administration (TGA) is encouraging members of the Australian dental industry to report non-compliant dental devices in the Australian market. Your report will help safeguard the health of the Australian community and maintain a level playing field in the industry.

The TGA regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989 (the Act). Unless a specific exemption applies, medical devices must be included on the Australian Register of Therapeutic Goods (ARTG)  before they can be supplied in Australia.

The term ‘medical device’ covers a large range of products including dental instruments, dental fillings, amalgams and orthodontics. Devices entered onto the ARTG have been certified by the product's Australian supplier as being manufactured according to internationally recognised standards for quality, safety and performance.

The regulatory scheme is important to the safety of Australian consumers. The TGA monitors unlawfully supplied products and takes appropriate regulatory action where necessary, ranging from education and support through to court proceedings.

If you suspect a medical device is non-compliant, you can notify the TGA anonymously by emailing ECT@health.gov.au or by calling 1800 020 653. Information provided should include sufficient details for further enquires to be undertaken.

You can also report illegal or questionable practices and make advertising complaints online.

— Source: Therapeutic Goods Administration

Currency & Disclaimer —

This update was issued on 7 June 2019 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 

 

This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated. 

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