Medical Device Reform Legislation Looks Set To Pass
28th Mar 17
A Senate Committee report recommending the Australian Parliament pass proposed amendments to the Therapeutic Goods Act (Cth) 1989 paves the way for a big cut to the red tape faced by dental product manufacturers and suppliers.
Key Issues For The Dental Industry —
A Senate Committee report recommending the Australian Parliament pass proposed amendments to the Therapeutic Goods Act (Cth) 1989 represents a significant policy win for members of the Australian Dental Industry Association (ADIA). It is the outcome of sustained advocacy on the part of ADIA that started with the review of medicines and medical device regulation to reduce the red tape faced by the dental industry.
The Therapeutic Goods Amendment (20016 Measures No. 1) Bill 2016, if enacted, allows the Therapeutic Goods Administration (TGA) to decrease the regulatory burden on manufacturers and suppliers of dental products through:
Designation Of Australian Conformity Assessment Bodies —
The amendments facilitate the designation by the TGA of new third-party conformity assessment bodies which will, once active, provide a pathway for the timely regulatory approval of new and innovative medical devices to the Australian market. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Special Access Scheme Notification Scheme —
The change streamlines administration of the Special Access Scheme for Category B patients, providing a simpler pathway to access medical devices not on the ARTG. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Maintaining A Responsive Regulatory System —
ADIA believes that an appropriate balance has been struck with respect to limiting the number of persons who exercise delegated decision-making powers and the need for the Act to afford the TGA the ability to ensure that the regulatory system for the approval of medical devices is responsive to new and innovative diagnostic treatment options. ADIA has has advised the Senate that these changes are therefore supported by the dental industry.
Strengthening Post-Marketing Activity —
ADIA has long argued for the TGA to place increased emphasis on its post-market activities and the increased emphasis on data collection and interrogation, adverse event reporting and information exchange with overseas therapeutic product regulators is welcomed.
The bill had been referred to the Senate's community affairs legislation committee which handed down its report on 27 March 2017. The committee's recommendations reflect ADIA's advice to Senators that the legislation pass.
Senate Community Affairs Committee Key Documentation —
Senate Community Affairs Committee - TGA Amendment Bill Committee Report [PDF]
Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 [PDF]
ADIA Submission to the senate's community affairs committee [PDF]
Of particular importance to the dental industry are amendments within the bill that will enable the Department of Health to designate Australian companies, in addition to the TGA, to undertake conformity assessments of medical devices. Conformity assessment is the systematic examination of evidence and procedures to determine the safety of a medical device and whether it is acceptable and performs as intended. These conformity assessments will be used in deciding whether medical devices should be included in the Australian Register of Therapeutic Goods (ARTG), the list of medial devices, medicines and other therapeutic products that can be lawfully supplied in Australia. This alternative approach for conformity assessment will provide a faster and possibly cheaper market approval pathway for innovative patient diagnostic and treatment products. It's a long over due reform, one that ADIA has been a strong proponent for, so we look forward to the passage of the legislation that will see this become a reality.
The changes are the initial instalment of a reform program arising from an expert review of medicines and medical device regulation. The Australian Government’s response to this review released in 2016 and was endorsed by ADIA.
In actively lobbying for reform, ADIA's goal is a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. The passage of this bill is an important milestone towards this goal
This is a major reform for the dental industry, and a significant policy win by ADIA that supports dental product manufacturers and suppliers. ADIA's work in this area reflects the commitments made in the ADIA Advocacy Agenda to ensure that the medical device regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. Resources to achieve this have been made available by the ADIA Board as a result of commitments made in the 2016-20 ADIA Strategic Plan.
Member Engagement —
Businesses that manufacture and supply dental products drive ADIA's policy advocacy priorities and, with respect to the regulation of therapeutic goods, do this through the ADIA-DRC Dental Regulation Committee with updates 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 for ADIA's activities to support dental product manufacturers and suppliers in this area contact the ADIA Advocacy Team via email at firstname.lastname@example.org. 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 3 March 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.
21st Apr 17
New determinations of ADIA Code of Practice complaints have confirmed it's not possible to provide healthcare professionals with gift cards. New guidance is also available on the provision of other gifts with dental product purchases.
9th Apr 18
The Australian Government has released new guidance as to how the Therapeutic Goods Administration (TGA) implements cost recovery activities associated with the regulation of medicines and medical devices.