Minister Steps In To Help Business Introduce New Products
17th Oct 18
Ensuring that the medical devices regulatory framework supports the rapid introduction of innovative dental products was the major topic of discussions between the industry and Health Minister in parliament house.
Key Issues For The Dental Industry —
One of the greatest challenges facing businesses in the dental industry, and particularly small businesses, is navigating the medical devices regulatory framework when introducing new and innovative dental products. Reviewing options to expedite regulatory approval of these products was a key discussion point between the Minister for Health, the Hon Greg Hunt MP, and representatives of the Australian Dental Industry Association (ADIA).
The meeting was held in parliament house on 16 October 2018.
Over the course of the past two years the nation’s regulator of dental products, the Therapeutic Goods Administration (TGA), has seen its legislative framework change significantly with reduced market approval times for locally manufactured dental products and also those exported. There remain challenges when introducing new products that fall outside the scope of the TGA’s regulatory framework.
The ADIA membership are pioneers in introducing new technologies that support enhanced dental and oral healthcare. These include 3D printing and medical devices with a medicine.
In meeting with ADIA representatives in parliament house, the Health Minister took great interest in the work of ADIA member businesses in introducing these innovative dental products and discussed the regulatory challenges the industry faces.
One important outcome of the meeting was the Minister’s commitment that the Australian Government would meet on a quarterly basis with the dental industry to review roadblocks in market approval. These discussions will help frame the context of future regulatory reviews. ADIA members have the opportunity to provide input into the issues discussed via their participation in the ADIA-PRPC Product Regulation Policy Committee.
The meeting was one of several held during the day as ADIA convened its annual Dental Industry Meets Parliament Roundtable. On the evening prior to the event the Medical Devices Small Business Coalition (MDSBC) was launched, an initiative spearheaded by ADIA with the MDSBC formally launched by the Minister for Health.
Further Information —
The ADIA Policy Team negotiating with the Australian Government on matters of dental product regulation receives advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA on fees and charges send an email to email@example.com or telephone 1300 943 093.
Currency & Disclaimer —
This update was issued on 17 October 2018 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.
|A —.. A D I A . .S T R A T E G I C . .A L L I A N C E S
15th Aug 18
The dental industry is playing a lead role in supporting the TGA develop industry guidance on the 2018 TGA Therapeutic Goods Advertising Code, a document that sets clear standards for advertising medical devices to consumers.
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.