WHAT NEWS?
ADIA - ADIA Dental Regulation Update: TGA Premarket Assessment Of Medical Devices

Summary - ADIA has reviewed TGA proposals to reform the regulatory standards governing the premarket assessment of medical devices. Changes include an increase in the number of products targeted for mandatory audits to include some Class IIb implantable and long term surgically invasive medical devices, but not dental implants. ADIA has also supported proposals to abolish the requirement for Australian manufacturers of medical devices to have TGA conformity assessment for all medical devices (except for Class 4 IVDs), instead relying on that of a European notified body.

Key Issues For The Dental Industry - As the peak representative body for suppliers of quality dental products, the Australian Dental Industry Association (ADIA) has reviewed the Regulatory Impact Statement (RIS) exposure draft that examines options to reform premarket assessment requirements for medical devices that was prepared by the Therapeutic Goods Administration (TGA). Having reviewed the three reform options set out by the TGA, ADIA advises that the second option is the dental industry’s preferred reform pathway. A copy of ADIA's submission is attached.

The reform pathway supported by ADIA in its submission proposes to increase scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion has two elements.

The first element is to increase the number of products targeted for mandatory audits to include some Class IIb implantable and long term surgically invasive devices. Based upon advice provided to ADIA by the TGA that dental implants are now excluded from the revised proposal to increase the number of products targeted for mandatory audits to include some Class IIb implantable and long term surgically invasive devices, ADIA supports the proposal. Initially, dental implants were to be included within the scope of this reform however after a concerted policy advocacy campaign by ADIA, this proposal was withdrawn.

The second element is to introduce a new Level 3 audit to assess additional evidence of conformity for Active Implantable Medical Devices (AIMD) and Class III implantable medical devices together with a fee commensurate to the additional analysis required. As this proposal does not largely affect the dental industry, following advice from ADIA member businesses no comment was offered as to the merits of the proposal.

The reform pathway supported by ADIA also proposes to support the publishing information on the regulatory decisions the TGA makes about medical devices and IVDs. The paper suggests that the format for publishing all medical devices decisions will assume a format similar to the AusPAR (Australian Public Assessment Reports for prescription medicines). In its submission, ADIA has reiterated earlier advice to the TGA concerning the potential release of information that is commercially sensitive and may, through misinterpretation or misuse, damage a medical device manufacturer and / or sponsor.

The final element of the reform pathway supported by ADIA proposes to abolish the requirement for Australian manufacturers of medical devices to have TGA conformity assessment for all medical devices (except for Class 4 IVDs). The outcome would be that, except for Class 4 IVDs, an Australian manufacturer could choose to have their conformity assessment certificates issued by a European notified body rather than being limited to using the TGA. This was strongly supported by ADIA.

The Australian Dental Association (ADA), the representative body for the dental profession, has tendered separate and contradictory advice to the TGA that that ADA supports the inclusion of dental implants in the TGA's increased premarket assessment regime. Such an outcome would significantly increase costs for suppliers of dental implants with adverse price pressures flowing through to patients. However, this is unlikely to be the outcome given that ADIA successfully lobbied to exclude dental implants from the proposed regulatory solution.

ADIA's policy objective is to achieve an outcome that supports the growth of member businesses, both small and large.  If you would like further information, please feel free to contact ADIA Chief Executive Officer, Troy Williams, via email at troy.williams@adia.org.au or by telephone on 1300 943 094.
Finally, subscribe to ADIA's Twitter feed @AusDental to keep up to date with any changes in this area.

ADIA Member Engagement - The reform submissions were reviewed by members of the ADIA-DRC Dental Regulation Committee, the forum which allows suppliers of quality dental product the opportunity to understand and positively influence changes to the commercial, technical and regulatory environment.

Currency of Information - This update was issued on 9 June 2013 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.

Disclaimer - 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.


INFODENT Srl

Str. Cassia Nord Km 86,300
01100 Viterbo - Italy
T +39 0761 352198
F +39 0761 352133
VAT: IT01612570562
iso_mark

© 2012 Infodent International. - All rights reserved

Forgot your password? Enter the email address for your account.
An email will be sent allowing you to reset it.
Submit