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


TGA Implant Card Proposal To Increase Red Tape

TGA Implant Card Proposal To Increase Red Tape

9th Oct 17

Summary —

The Therapeutic Goods Administration (TGA) is proposing that dental product manufacturers provide an information card when supplying a medical device as an outcome of alignment of Australia's medical device regulations with that of the European Union (EU).

Key Issues For The Dental Industry —

The Australian Dental Industry Association (ADIA) has been asked by the TGA to consider the implication of regulatory alignment with the EU that, if implemented, would increase the regulatory burden on dental implant manufacturers by requiring them to provide a information card to patients.  Having reviewed the matter members serving on the ADIA-IIG Implant Interest Group raised several practical problems associated with the proposal which are relevant in the Australian context.

The TGA's proposal stems from a broad and far-reaching intent to align Australia's regulatory framework with that of the EU, in this specific instance with the requirements of EU2017/745.  Under the new requirements, implant manufacturers would be required to create and ensure the provision of physical cards to patients containing the information:

Information To Be Provided On An Implant Card —

The device including the name, serial number, lot number, unique device identifier (UDI) and device model;
The manufacturer' name, address and website;
Warnings, precautions, or measures that should be taken by the patient or healthcare professional;
Guidance on the expected lifetime of the device and follow up information; and
Safety information including the materials and substances that the patients can be exposed to.

The information on the cards duplicates to a large extent what a manufacturer already has to provide, under the Therapeutic Goods (Medical Device) Regulations (Cth) 2002, with a medical device, and is therefore considered to be an unnecessary duplication and red tape. A detailed analysis of the proposal can be found by downloading the TGA's consultation paper and ADIA's discussion paper released in response.

Key Downloads —

TGA Consultation Paper - EU Regulatory Alignment [PDF] *
ADIA Discussion Paper - Implant information cards [PDF] *

It is assumed that suppliers will also bear some degree of responsibility for ensuring that the cards are transmitted from the manufacturer to the healthcare professional. While sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors are all excluded from this requirement, dental implants will fall under the requirement.

Challenges with the implant card proposal —

Manufactures will need to produce physical cards and ensure appropriate guidance is provide to healthcare professionals.
Suppliers are likely to have an obligation to ensure that the cards are provided to patients.
The information on the cards duplicates what is already required in the Therapeutic Goods (Medical Devices) Essential Principles (EPs) and is therefore unnecessary duplication and red tape.
The TGA has not considered the need for regulation, has not measured the impact of the regulation on industry, and has not taken into account the difference in risk between different classes of implant.
The TGA appears to have annexed the EU regulation without considering whether it is necessary or appropriate in Australia.

ADIA has also noted that the requirement for dental implant manufacturers to supply a physical 'card' is incongruous with the National Digital Health Strategy which seeks to modernise health service delivery so that it is more effective and efficient.   State-wide electronic medical record initiatives and local innovations that bring together data and transform decision support have led to a need for agreement on a national set of priorities to guide the diverse players in the health sector towards common goals for better connected digital services.

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-IIG Implant Interest Group and the ADIA-PRPC Product Regulation Policy Committee.

Currency & Disclaimer —

This update was issued on 9 October 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. 

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