ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

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TGA Implant Card Proposals To Increase Red Tape

TGA Implant Card Proposals To Increase Red Tape

25th Aug 17

Summary —

Proposals By The Therapeutic Goods Administration (TGA) for manufacturers of dental implants to provide information directly to the patient have raised a number of compliance issues and, if implemented, look set to significantly increase the red-tape burden faced by dental product manufacturers.

Key Issues For The Dental Industry —

The proposal for patient implant cards stems from a commitment of the Australian Government to align, wherever possible, Australia’s medical device regulatory requirements with those of the European Union.    It’s in this context that the proposal is being considered by the TGA as revised European regulations on medical devices, agreed on 5 April 2017, included significant changes to the previous regulatory arrangements including the introduction of an ‘implant card’ containing information about implanted medical devices for a patient. 

The TGA’s essential principles for medical devices (the safety performance standards) currently require certain information be provided by manufacturers with medical devices including information:

  Identifying the device
  Identifying the manufacturer of the device
  Explaining how to use the device safely, having regard to the training and knowledge of potential users of the device
  Detailing any warnings, restrictions, precautions, side effects or residual risks in relation to the use of the device
  Detailing risks arising, because of other equipment, for example magnetic field interference from magnetic resonance imaging devices

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However, the Essential Principles do not make explicit the requirement for provision of the device information or any cautionary information to the patient.

The new European Union regulations require that manufacturers of implantable devices shall provide together with the device the following:

  Information allowing the identification of the device, including the device name, serial number, lot number, the Unique Device Identifier (UDI), the device model, as well as the name, address and the website of the manufacturer
  Any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions
  Any information about the expected lifetime of the device and any necessary follow-up
  Any other information to ensure safe use of the device by the patient including (the overall qualitative and quantitative information on the materials and substances to which patients can be exposed).

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This information shall be provided on an implant card delivered with the device which healthcare professionals will be required to provide to the patient.  The European Union regulations require that the information is to be written in a way that is readily understood by a lay person and updated where appropriate.  Under the European Union regulations any updates of the information shall be made available to the patient via a website. 

The TGA has stated that the proposed change to the medical device regulatory framework would parallel the new European Union requirements, making the requirement for patient cards and information explicit in the regulations, to improve information flow to patients and doctors, and to assist in improving patient-doctor discussions.

A joint meeting of the ADIA-PRPC Product Regulation Policy Committee and the ADIA-IIG Implant Interest Group has determined that, for dental implants, the proposed adoption of the European Union regulatory approach is highly problematic.  The TGA has provided no advice to how there can be confidence that a patient implant card is actually provided to the recipient of the device.  Similarly, there is no guidance as to how, if at all, any TGA regulatory obligations will align with Australian Digital Health Agency requirements for the Personally Controlled Electronic Health Record (PCEHR).  

ADIA members with an interest in this matter are encourage to get involved with the ADIA-IIG Implant Interest Group which is supporting ADIA’s policy team in providing the TGA with advice and guidance on this point.

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 to matters associated with the regulation of dental implants, ADIA staff responsible for negotiating policy outcomes with government receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee and the ADIA-IIG Implant Interest Group. Member updates are provided at the quarterly series of ADIA State Branch Briefings.

Further Information —

If you have an interest in ADIA's efforts to reform the regulatory standards for equipment installation, for updates subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at advocacy@adia.org.au or by telephone on 1300 943 094.

Currency Of Information & Disclaimer —

This update was issued on 1 September 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 information 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.

 

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