Dental Industry Red Tape Index Jumps Ten Points
26th Sep 17
The Australian Dental Industry Red Tape Index the fourth quarter of FY2016-17 jumped significantly to 58.7, indicating a moderate increase in regulatory compliance costs for the businesses that manufacture and supply dental products.
Key Issues For The Dental Industry —
The Australian Dental Industry Red Tape Index is a measure of the regulatory compliance burden faced by manufacturers and suppliers of dental products. It is produced on a quarterly basis using data furnished by members of the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of dental products.
The regulatory compliance burden, colloquially known as government red tape, faced by businesses in the Australian dental industry takes many forms; however, it is typified by unduly high government fees, excessive regulation and rigid conformity to formal rules by government that is redundant or bureaucratic and hinders or prevents action or decision-making on the part of both business and government itself.
FY2016-17 Fourth Quarter Reading —
58.7 Indicating A Moderate To High Increase In Red Tape
The most recent survey to produce the longitudinal study of the dental industry's red tape compliance burden covers the third quarter of FY2015-16.
It produces an index reading of 58.7 which indicates a moderate in red tape compared to the previous quarter. This was a significant jump from the previous quarter's reading of 48.6 and out of sequence for a two-year downward trend that started in the first quarter of FY2015-16.
Survey respondents indicated that this outcome is attributed to the continuing compliance costs associated with meeting the Therapeutic Goods Administration (TGA) requirements to obtain market approval for for new medical devices getting, highlighting the need for the Australian Government to expedite the reforms arising from thereview into medicines and medical device regulation that will simplify TGA processes.
Businesses were surveyed on the red tape burden on their business for the period covering April to June 2017 (inclusive) with the survey being completed over 3-18 June 2017 by 37% of the ADIA membership that manufacture and / or supply dental products.
The adverse impacts of red tape on businesses in the dental industry often manifest themselves in delays and costs associated with any delays in time to market, or changes to production processes; and development of products to meet Australian-only product design, performance and testing standards.
Businesses that manufacture and supply dental products are amongst the most regulated in the nation, largely due to the regulatory standards for the approval of dental products. Agencies responsible for creating red tape include the: Australian Taxation Office (ATO); Australian Securities and Investments Commission (ASIC); National Industrial Chemicals Notification and Assessment Scheme (NICNAS); and the TGA.
Understanding the index reading —
An index level of 50 indicates that there is an exact balance between those businesses who responded that the regulatory compliance burden is increasing and those who replied that the regulatory compliance burden had declined. Thus, a level below 50 can generally be interpreted as meaning the regulatory compliance burden is falling, and conversely, a reading above 50 indicates the regulatory compliance burden is increasing.
The Australian Dental Industry Red Tape Index helps form the context for ADIA’s policy advocacy which is directed towards securing a regulatory framework for dental products based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from an unnecessary regulatory burden.
As the ADIA membership supplies more than 95% of the products in Australian dentistry, the Australian Dental Industry Red Tape Index is viewed by government and industry stakeholders as an accurate barometer of the regulatory compliance burden faced by businesses in the medical technology sector.
Member engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to matters associated with assessing the red tape face by business, ADIA staff responsible for policy advocacy receive advice and guidance from members serving on the ADIA-TCPC Trade & Commercial Policy Committee and the ADIA-PRPC Product Regulation Policy Committee.
Currency of Information —
This update was issued on 26 September 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, other images and where otherwise stated.
8th Nov 18
The Therapeutic Goods Administration (TGA) has issued new guidance material setting out requirements on businesses that advertise medical devices direct to the public.
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.