TGA Draft Clinical Evidence Guidelines
30th Mar 16
ADIA members are currently reviewing draft guidelines that outline TGA expectations for clinical evaluation reports and underlying evidence to be held by medical device manufacturers as part of their conformity assessment procedures.
Key Issues For The Dental Industry —
As the peak business organisation representing manufacturers and suppliers of dental products, the Australian Dental Industry Association (ADIA) has been asked by the Therapeutic Goods Administration (TGA) to comment on the draft clinical evidence guidelines for medical devices.
To provide confidence in the Australian healthcare system and to help ensure the health of the Australian population, all medical devices supplied in Australia must have clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose(s). Medical devices supplied in Australia must also be included on the Australian Register of Therapeutic Goods (ARTG) unless exempt or excluded. The draft guidelines aim to provide more clarity around the Australian regulatory decision making process and the practicalities of the clinical assessment of medical devices within the Australian regulatory framework. This is firmly based on the evaluation of the clinical evidence of safety and performance of medical devices. The intended result is to assist sponsors and manufacturers to move efficiently through the regulatory system.
The guidelines are intended to assist sponsors and manufacturers of medical devices seeking to supply their products in Australia, to compile relevant and complete clinical evaluation reports for their devices to meet the regulatory requirements.
The guidelines are being reviewed by the ADIA-DRC Dental Regulation Committee and to ensure that the views of the dental industry are reflected in ADIA's advice to the TGA affected member businesses have been invited to tender their advice concerning the draft. Further information is availabe via the link below:
The draft guidlines have been developed by the TGA taking into account requirements of the Therapeutic Goods Act (Cth) 1989 and the Therapeutic Goods (Medical Devices) Regulations (Cth) 2002. The draft document references and aligns with international guidance documents including those of the Global Harmonization Task Force (GHTF) and the European Commission ‘MEDDEVs’ which are also based on the GHTF (The GHTF no longer exists, and has been permanently replaced by the International Medical Device Regulators Forum) guidelines.
It is important to note that the (draft) guidelines are a guide only and business is encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary seek professional advice as it is the responsibility of each sponsor to understand and comply with these requirements.
ADIA member businesses with an interest in this matter are encouraged to review the consultation page referenced above.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. On matters associated with tax policy, ADIA staff that negotiate with the Australian Government at a parliamentary and departmental level receive advice and guidance from members that who serve on the ADIA-DRC Dental Regulation Committee.
Currency of Information —
This update was issued on 30 March 2016 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.
15th Oct 18
A change to the way the Therapeutic Goods Administration (TGA) calculates fees for placing products on the register of medical devices that can be lawfully supplied will support dental product exporters.
22nd Aug 18
If your business is regulated by ASIC it may be required to submit information to the the Australian Government that will be used to determine the fees that will be paid. The reporting deadline is 27 September 2017.