Reporting Illegal Supply Of Dental Products
19th Jul 16
The TGA has statutory responsibility for regulating the supply of medical devices supported by a mechanism to report alleged incidences of illegal supply of dental products and other medical devices.
Key Issues For Consideration —
The Therapeutic Goods Administration (TGA) was established to safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods, the latter which includes many types of dental products. The TGA does this through the application of the Therapeutic Goods Act (Cth) 1989.
Medical devices that are approved for supply in Australia have been entered into a national database called the Australian Register of Therapeutic Goods (ARTG), which is maintained by the TGA. When buying a medical device, the TGA advises to only choose a medical device that has been included on the ARTG.
Unless a specific exemption has been granted, it is a criminal offence under the Therapeutic Goods Act (Cth) 1989 to import into, supply in or export from Australia a medical device that has not been entered onto the ARTG.
||Reporting cases of illegal supply —
Any person or business that has concerns that a dental product has been supplied in Australia without being included on the ARTG when this is required are encouraged to report this to the TGA. This can be done by writing to:
Regulatory Investigations and Enforcement Section
Therapeutic Goods Administration
PO Box 100, Woden, ACT, 2606
There is also an online form that you can complete that can be accessed via the link below:
TGA Online Form – Reporting
When forwarding a complaint to the TGA be sure to provide as much information as you can. Documentary evidence is a great way to assist the TGA fully investigate allegations of illegal supply.
The TGA exercises a risk-based approach to prioritise complaints and other signals of possible non-compliance with regulatory requirements, in order to provide the greatest overall benefit for the Australian public. The actions taken by the TGA in response to signals of potential non-compliance will depend on the likely risk associated with the non-compliance. The following criteria are indicative of the factors guiding the prioritisation of TGA's monitoring and compliance actions:
||Issues that may have adverse health consequences for consumers as a result of public access to inappropriate or dangerous goods.
||Issues that may affect TGA's reputation among key stakeholders leading to a loss of confidence in the TGA's regulatory processes and subsequently loss of confidence in available therapeutic goods.
In cases where the TGA decides not to engage in regulatory action in relation to non-compliance, the TGA may provide information to the party to help deal with the issue and gain a better understanding of the legislation. The TGA may also draw the possibilities of contraventions of legislation to the attention of the party and provide information to encourage rectification and future compliance. Conversely, where parties have attempted to correct possible contraventions and provide information to prevent recurrence the TGA may deal with a matter informally.
Where appropriate, the TGA works with other agencies in performing its monitoring and compliance functions. This may involve an exchange of information, or more direct engagement in joint investigatory activities.
Member Engagement —
On matters concerning dental product regulation ADIA Board and staff receives advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee.
Currency of Information —
This update was issued on 19 July 2016 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.
23rd Oct 18
The TGA has released guidance on the information that must be provided to patients with certain types of implantable medical devices, having regards for the fact that most dental implants are excluded from this requirement.
21st Aug 18
The annual Dental Industry Meets Parliament Roundtable on 16 October 2018 provides an opportunity for member businesses to raise issues with those able to shape the commercial, technical, and regulatory environment in which the dental