$10M Maximum Penalty For Illegal Dental Product Supply
16th May 17
From 1 July 2017 the maximum penalty for the importation or supply of dental products without first meeting Therapeutic Goods Administration (TGA) requirements will exceed $1 million for individuals and $10 million for companies.
Key Issues For The Dental Industry —
A recent legislative amendment has increased the maximum penalty that individuals and companies may face for illegally importing dental products then supplying these products locally or using them on patients.
For regulatory purposes most dental products are defined as "medical devices" by the Therapeutic Goods Act (Cth) 1989 and subject to the TGA's complex regulatory standards that place significant obligations on those manufacturing, importing, exporting and supplying medical devices. The increased fines are directed at those seeking to import medical devices then supply them locally or use them on patients.
If a health professional supplies a medical device to the Australian market – and the legal definition of supply includes using products in clinical practice – they become legally responsible for meeting the TGA’s requirements. These include applying to the TGA to have each kind of medical device included on the Australian Register of Therapeutic Goods (ARTG) unless a specific exemption applies; ensuring the device continues to meet all legislative requirements once on the market; reporting any adverse events or problems; and taking corrective or preventative action, such as recalls, if necessary.
The chatter in some online forums is that it’s okay to buy medical devices from overseas then supply the products locally or use them on patients. Such importers need to be sure the products meet the TGA’s standards, the "essential principles", concerning safety and performance characteristics of medical devices. They also need to ensure that a quality management system was in place with regards to the manufacturing process. They the then need to apply to the TGA for an ARTG entry for each kind of medical device, even if another business already has an ARTG entry for the same product.
Under the legislation, a person faces a fine of up to $1,050,000 if they supply a medical device for use in Australia that does not comply with the essential principles in circumstances where the TGA has not consented to the supply or a specific exemption has not been granted. A company faces a fine of up to $10,500,000 in such circumstances.
The increased fines are a clear sign that the TGA views as a serious offence the act of importing medical devices into Australia then supplying these products locally or using them on patients without the requirements of the Therapeutic Goods Act (Cth) 1989 having been met.
The higher penalties will come into force on 1 July 2017 and arise from passage in the commonwealth parliament on 11 May 2017 of the Crimes Amendment (Penalty Unit) Bill (Cth) 2017 that increased the amount of the Commonwealth penalty unit from $180 to $210 from 1 July 2017.
Member Engagement —
On matters associated with dental product regulation the team in the ADIA national office receives advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee. Updates on the research are provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.
Further Information —
For further information from ADIA's on matters associated with dental product regulation send an email to email@example.com or telephone 1300 943 094. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 16 May 2017 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, images and where stated.
5th Jan 18
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4th Apr 19
The Therapeutic Goods Administration (TGA) has released its ‘Action Plan for Medical Devices’. The Action Plan is made from a three-part strategy than plans to further strengthen Australia’s regulatory requirements.