proposal paper on changes to premarket assessment … · 2014-08-08 · tga medical device...

TGA Medical Device Reforms - Australian Dental Industry Association Submission

Table of Contents

The responses in this submission focus on· the two key elements of the pre market assessment process - conformity assessment and approval for marketing through inclusion on the Australian Register of Therapeutic Goods (ARTG).

Executive summary

Proposal A- Expansion of the mandatory audit program

Proposal 8 - Publication of TGA regulatory decisions

Proposal C- Low risk medical device conformity assessment

Appendix A- The Australian Dental Industry Association

Appendix 8- Abbreviations

Page 3

Page 4

Page 8

Page 12

Page 14

Page 15

ADIA Reference: 11.10.10

ADIA Twitter Feed @AusDental

ADIA On Facebook www.facebook.com/dental.industry

ADIA ��W�� ,;ntal Industry Association Inc.

National Office: GPO Box 960, Sydney, NSW, 2001 Government Affairs: GPO Box 1, Canberra, ACT, 2601

t: 1300 943 094 f: 1300 943 794 e: [email protected] twitter: @AusDental

www.adia.org.au

© 2013- Australian Dental Industry Association Incorporated

All rights reserved. No part of this publication may be reproduced in any material form or transmitted to any other person without the prior written permission of the Australian Dental Industry Association Incorporated except as permitted under the Copyright Act (Cth) 1968 (as amended) or unless expressly permitted in writing by the Australian Dental Industry Association. Such license is granted to Government.

Executive Summary

TGA Medical Device Reforms- Australian Dental Industry Association Submission

As the peak representative for suppliers. of quality dental products, the Australian Dental Industry Association (ADIA) is broadly supportive of the reform proposals representing as they do the evolution of the regulatory standards for the approval of medical devices. Through the nature of ADIA's interests, the following response is focused on the impact on dental products. An overview of the dental industry's response to the proposals is as follows:

Proposal A-

Increased scrutiny of conformity assessment as part of mandatory application

audits prior to ARTG inclusion.

The rationale for reform has not been established, particularly with reference to dental implants which are a Class lib medical device. The approach of simply expanding the list of medical devices specified under Regulation 5. 3 to include all surgically invasive devices intended for long term use and implantable medical devices without identifying a demonstrable problem is a departure from the established risk-management approach to medical device regulation previously supported by the TGA and all stakeholders.

Proposal B-Publication of TGA regulatory decisions.

ADIA supports the proposal with the strong qualification that what is published should be limited to information about the degree to which a medical device has been assessed prior to inclusion in the ARTG, with no publication of rejected applications or publication of information regarding conformity assessment of products that do not make their way on to the ARTG.

Proposal C-

Abolition of requirement for TGA conformity assessment for Australian

manufacturers of lower risk medical device.

A significant enhancement would be to extend the proposal to include Class lib medical devices that are surgically invasive devices intended for long term use and implantable medical devices ..

ADIA is of the view that all reform to the regulatory standards for the approval of medical devices should ensure that the Australian community has access, within a reasonable timeframe, to therapeutic advances. Furthermore, the dental industry believes that the regulatory framework should be 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.

We thank both the TGA for this opportunity to tender comment and look forward to further consultation on this matter.

Troy R Williams AFAIM MAICD

Chief Executive Officer Australian Dental Industry Association

19 February 2013


Proposal A - Expansion of the mandatory audit program

This proposal would expand the current mandatory audit program undertaken by the TGA, both in terms of the medical devices targeted for audit and the level of assessment undertaken in the audit process prior to inclusion of the medical devices in the ARTG. The elements of this proposal are: Targeting of mandatory audits; assessment of evidence of conformity; and the Audit fee.

Rationale for reform not established

The rationale for reform has not been established, particularly with reference to dental implants which are a Class lib medical device. The approach of simply expanding the list of medical devices specified under Regulation 5.3 to include all surgically invasive devices intended for long term use and implantable medical devices without identifying a demonstrable problem is a departure from the established risk-management approach to medical device regulation previously supported by the TGA and all stakeholders. The TGA has stated:

A number of reports and inquiries have emphasised the need to increase the

rigour of the TGA 's premarket assessment process for higher risk medical

devices, in particular implantable medical devices.

Proposal Paper: Changes to premarket assessment requirements for medical devices Therapeutic Good Administration - January 2013

The TGA has argued that recent events, such as the failure of the ASR hip joint replacement and the issues with the manufacture of Poly Implant Prosthese (PIP) breast implants, have highlighted these difficulties. However, referencing problems

. with two kinds of device is not sufficient reason for a blanket approach to significantly increasing the regulatory burden when no risk has been identified. _Although the TGA has stated that it will continue to reform its business processes to streamline the medical devices regulatory framework and refine its risk based approach to administering regulation, the proposal is a departure from that practice.

The TGA maintains the medical device Incident Reporting and Investigation Scheme (IRIS) , which is responsible for the management of all reports of adverse events or problems associated with medical devices. An adverse event is defined as an injury resulting from a medical intervention, not the underlying condition of the patient, and is unintended or unintentional harm or suffering arising from any aspect of health care management. Prior to progressing with this proposal, it is incumbent on the TGA to ·

disclose the number IRIS reports of adverse events associated with Class lib medical devices that are implantable or surgically invasive for long-term use, and then ascertain whether the proposal to expand the current mandatory audit program undertaken would have identified problems causing the adverse events.

Although this proposal does succeed in including a greater range of medical devices which are implantable or surgically invasive for long-term use within the scope of TGA approval, it


does not necessarily increase the level of public safety. This is primarily because the TGA has not identified problems noted in IRIS or elsewhere, particularly when dental products are concerned.

ERA Inconsistency

The proposal notes that where a European notified body ha.s issued a conformity assessment certificate under the Mutual Recognition Agreement (MRA) and undertaken the required confidence building, the TGA would select the application for a Level 1 audit. This currently does not occur where conformity assessment certification is issued under the MRA.

The proposal effectively sets aside a key purpose of the ERA which was to eliminate further premarket review by TGA of low risk products. It is an outcome that warrants review by the Department of Foreign Affairs and Trade (DFAT) in order to determine the consistency of the proposal with Australia's international treaty obligations.

Failure to address risk with dental products

In proposing to expand the current mandatory audit program undertaken by the TGA, an inexplicable dichotomy is created with respect to one· particular dental product that is colloquially but not entirely accurately referred to in the community as a dental implant and as a "maxillofacial implants" in the discussion paper.

There are three components to a dental implant which are noted in the diagram to the left. These am the: The implant that is screwed into the jaw (a Class lib medical device) ; the abutment (which depending on specialist advice and the method of manufacture is either a Class lib medical device or a custom-made medical device) ; and the crown (a custom-made medical device) .

The proposal creates a regulatory anomaly as the implant will be subject to a mandatory audit while the crown and, potentially the abutment, are free of such review. Advice to· the Senate's community affairs references committee into the inquiry into regulatory standards for the approval of medical devices in Australia noted:

... up to 50 per cent of custom made dental prostheses such as crowns, bridges,

dentures and some implants are sourced from overseas markets such as China,

India and Vietnam. Logic Appeal stated that these medical devices are not

validated by the TGA at the source of manufacture.

Report: Regulatory Standards For The Approval of Medical Devices In Australia Senate Community Affairs References Committee- November 2011

In this environment, the implant will be subject to increased scrutiny whereas the crown and possibly the abutment will not be subject to any conformity assessment whatsoever by the TGA. Although this dichotomy is due to the absence of effective regulatory standards for custom-made medical devices (which ADIA has previously

TGA Medical Device Reforms - Page Ei Australian Dental Industry Association Submission

raised with the TGA) , it does underpin the potential ineffectiveness of the proposal to expand the current mandatory audit program undertaken by the TGA as far as dental implants is concerned.

The discussion paper makes reference to the two levels of mandatory audit fee which if applied reflects the level of analysis to be undertaken, with the current fees being $3,360 for a Level 1 application audit and $6,170 for a Level 2 application audit.. ADIA believes it prudent to note that these fees do not represent the true cost of these proposals to industry. It is anticipated that business will incur indirect costs (beyond the TGA's fees) that are a multiple of four to seven times the current application fee if the proposal is progressed.

TGA Request for guidance on proposals

In the discussion paper, the TGA has set out four questions and ADIA tenders for consideration the following responses tendered on the advice set out above:

Question 1: Are the medical devices outlined above appropriate targets for greater premarket scrutiny? Response: No, the arbitrary expansion of the current mandatory audit program undertaken by the TGA to include all surgically invasive devices intended for long term use and implantable medical devices is inappropriate. Before proceeding, it is incumbent on the TGA to identify the adverse events or other demonstrable problem which provide a basis for reform.

Question 2: Have any other medical devices which should be included been missed?

. Response: Consistent with its commitment to developing and administering regulatory standards for medical devices based on a risk-management approach, only those products where identifiable adverse events should be subject to the proposaL As the proposal stands, the number of products included is too great.

Question 3: What are the risks and benefits of this proposal? Response: If progressed in its current form the proposal has two direct adverse impacts on delivery of healthcare. The first is that it unnecessarily increases the regulatory compliance burden on business thus raising the costs of healthcare. The second is that it unnecessarily increases the time taken to introduce new and innovative products.

Question 4: Which elements of the proposal could be removed without reducing the premarket regulatory rigour of higher risk medical devices? Response: Unless IRIS and other reputable, verifiable sources of data present identify a record of adverse events associated with Class lib medical devices, a strong case can be made that the current premarket regulatory rigour is commensurate with the demonstrable risk thus no reform is necessary for this product class.


As it stands, the proposal to expand the current mandatory audit program undertaken by the TGA for to include all surgically invasive devices intended for long term use and implantable medical devices lacks merit for the reason highlighted by ADIA.

ADIA believes it appropriate that the TGA recommit to a regulatory framework for the approval of medical devices which ensures therapeutic goods avail�ble in Australia are of an acceptable standard and where the TGA ensures that the Australian community has access, within a reasonable timeframe, to therapeutic advances. The regulatory framework should be 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 proposal is inconsistent with this principle.


Proposal 8 - Publication of TGA regulatory decisions

The discussion paper canvasses options to improve the transparency and accountability in the TGA's decision making processes by publishing information on the regulatory decisions the TGA makes on medical devices. This is particularly focused on providing information about the degree to which a medical device has been assessed prior to inclusion in the ARTG (for example whether the medical device has been audited, and the evidence considered in that audit which in practice may vary significantly between applications, or the extent to which TGA conformity assessments have been abridged).

Qualified support for proposal

ADIA supports the proposal with the strong qualification that what is published should be limited to information about the degree to which a medical device has been assessed prior to inclusion in the ARTG, with no publication of rejected applications. Furthermore, ADIA does not believe it appropriate to publish information concerning decisions on conformity assessment for products which no application has been made to place the product on the ARTG.

ADIA takes at face value the TGA's commitment that no confidential information revealed to the TGA will be released into the public domain, for example intellectual property relating to the medical device and commercial arrangements between manufacturer and Australian sponsor. If the TGA departs from this principle, ADIA support can be considered to be withdrawn.

Publication of non-approvals

The TGA has proposed that this could also include decisions on medical devices for which applications were not approved, for which there is currently no public visibility. The case for this proposal has not been set out by the TGA.

Consistent with its support that the proposal should be limited to providing information about the degree to which a medical device has been assessed prior to inclusion in the ARTG, ADIA does not support the proposal to publish decisions on medical devices for which applications were not approved as:

• If the product does not appear on the ARTG there is no basis to publish the information; and

• Publication of a decision to include a medical device on the ARTG is inconsistent with providing advice about the degree of assessment. Publishing information about the degree to which a medical device has been

assessed is about process, whereas a decision not to include a product on the ARTG is about outcomes.

Advice from the dental industry is that this proposal may serve to reduce the introduction of new and innovative products to the Australian market, thus undermining

TGA Medical Devic.e Reforms- Australian Dental Industry Association Submission

a stated goal of the TGA to ensure that the Australian community has access, within a reasonable timeframe, to therapeutic advances.

There are many reasons that an application to place a medical device on the ARTG may be not be successful, it some cases it may be withdrawn due to the excessive and supererogatory regulatory burden that the TGA places on business. Many reasons will be administrative in nature and unrelated to the efficacy or safety of a medical device. However it is reasonable to .assume that patients and the general consumer population may draw an unsubstantiated conclusion that a product is unsafe due to a decision (however based) not to include it on the ARTG. It is difficult to understate the concern that business has with such an unfortunate scenario. The TGA transparency review noted:

However, some sectors of the industry raised concerns that making this

information publicly available would possibly notify competitors of commercial

decisions, e.g. to withdraw an application during the assessment process, and

identify commercially sensitive material.

Report: Review To Improve The Transparency Of The Therapeutic Goods Administration Department of Health & Ageing - June 2011

Further, there are also concerns that repeated decisions not to place a product on the ARTG that are associated with one business may unnecessarily and without foundation, reflect poorly on the quality of medical devices manufactured and I or supplied by that business.

Business has expressed such reservations with this proposal that it has indicated that if implemented, it may reduce the number of applications to place new and innovative products on the ARTG where an application is likely to be unsuccessful in the first instance. In such circumstances, the regulatory standards for the approval of medical devices would be counter to the intended outcome of ensuring that the Australian community has access, within a reasonable timeframe, to therapeutic advances.

In the context of the Therapeutic Goods Act (Cth) 1989 there is no public interest nor beneficial patient outcomes in publishing an indication where applications for medical devices have been rejected. If this proposal is progressed, ADIA believes it appropriate that it be limited Class 1_11 medical devices and Active Implantable Medical Devices (AIMD) .

The basic test as to whether the TGA should publish information about its decision making . processes should be to guide patients about product available in the marketplace. There is

no case established that a patient (i.e. consumer) interest exists publishing information about products not available to them (i.e. has not appeared on the ARTG) .

Conformity assessment decisions

The dental industry has grave reservations that information about conformity assessment decisions related to medical devices that ultimately do not make their way onto the ARTG and other concerns with products that do.


TGA Decisions about conformity assessment may be made significantly in advance to an application being made to place a product on the ARTG. Such information is commercially sensitive as its publication would send a signal to a businesses' competitors about the possible entry of a product to market - an outcome that is not desirable and potentially commercially damaging to the business bringing a new product to market.

With respect to products that do make their way on to the ARTG, ADIA questions the need to publish information about any previous unsuccessful conformity assessment processes. As conformity assessment is a prerequisite for entry onto the ARTG, ADIA believes it is only appropriate to publish information about successful conformity assessment activities for product placed on the ARTG, as any negative outcome will predate the positive one thus the initial cause for rejection will have been addressed and a public record about a negative outcome may give rise to unnecessary public concern about the safety or efficacy of a medical device.

The proposal includes references to be made available ih relation to decisions associated with and 'more interesting' lower risk devices. The definition of 'more interesting' lower risk devices is not defined and it is appropriate that either a definition be developed or protocols be developed to ascertain in a transparent fashion what constitutes a 'more interesting' lower risk device.


In the discussion paper the TGA has set out four questions and ADIA tenders the following response tendered on the advice set out above:

Question 1: What are the risks and benefits of the proposal? Response: ADIA accepts that the proposal may improve transparency and accountability of the TGA's decision making processes, particularly in making clear the extent to which medical devices have been assessed prior to inclusion in the ARTG. However, business has expressed such reservations with the proposals in their current form that if implemented, it may reduce the number of applications to place new and innovative products on the ARTG, even where an application is likely to be successful. Furthermore, a deCision to publish information concerning decisions on conformity assessment for products which no application has been made to place the product on the ARTG may commercially damage Australian business without providing any patient benefit.

Question 2: What limits might be applied to publication of decisions, including which medical devices to which it might apply, or the way in which

·implementation might be phased in? ·

Response: The reforms should not include publishing an indication where applications for medical devices have been rejected, nor is it appropriate to publish information concerning decisions on conformity assessment for products which no application has been made to place the product on the ARTG.


If the proposal is progressed, ADIA believes it appropriate that it be limited Class Ill medical devices and AIMD that conformity assessment decisions.

The underpinning principle must be that no confidential information is released into the public domain where this information has been revealed to the TGA, for example intellectual property relating to the medical device and commercial arrangements between manufacturer and Australian sponsor.

On balance, ADIA supports a framework where information would only be made available in relation to decisions made for products appearing on the ARTG (thereby excluding those relating to applications for medical devices have been rejected) after a certain date and further consultation would occur about the information to be included and the ,mechanism by which is it published.


Proposal C - Low risk medical device conformity assessment

Under this proposal Australian manufacturers would no longer be required to seek TGA conformity assessment for lower risk medical devices (covering Class I, Is, lm, lla and lib non-implantable) . This would also apply for Australian manufacturers of IVDs (covering Class 1, 2 and 3 IVDs) .

Separation of proposals

The discussion paper states that it is anticipated that this proposal would only be implemented in conjunction with Proposal A, as the rationale for relaxing the requirements under this proposal, is to move towards alignment of requirements for all medical devices. In the absence of Proposal A being implemented, no progress is being made towards such alignment. ADIA queries this as a guiding principle as this proposal is of sufficient merit it should be progressed in any event.

This proposal is consistent with the objective of ensuring that the Australian community has access, within a reasonable timeframe, to therapeutic advances in an environment

· in which the regulatory framework is based on a risk management approach desig.ned to ensure public health and safety, while at the same time freeing industry from any

. unnecessary regulatory burden.

ADIA believes it to be in the public interest that Proposal C be progressed independently of Proposal A.

It is noted that the proposal to remove this requirement for Australian manufacturers to have TGA conformity assessment was included in the 2010 medical device reforms consultation and that respondents to the previous consultation on this option were largely supportive. ADIA would be supportive of extension of the proposal to include Class liB medical devices that are surgically invasive devices intended for long term use and implantable medical devices.


In the discussion paper the TGA has set out four questions and ADIA tenders the following responses tendered on the advice set out above:

Question 1: What are the risks and benefits of the proposal? Response: This proposal is a positive move for Australian manufacturers and will reduce the regulatory burden and in so doing, cut the costs and timeframes to introduce into the Australian market new and innovative technologies.

Question 2: Do you agree with our proposed position? If not explain why? Response: ADIA supports the proposal.

. . ./cont.


Question 3: Do you have any views on how this concept could be improved? Response: A significant enhancement would be to extend the proposal to include Class liB medical devices that are surgically invasive devices intended for long term use and implantable medical devices.

This proposal is consistent with ADIA's strong support for the TGA's recognition of third-party conformity assessment bodies. The practical application of the proposals is that Australian manufacturers would no longer be required to have TGA conformity assessment certification for any other medical device. In these cases, applicants could choose to rely on conformity assessment certification issued by European notified bodies to support applications for. the inclusion of their products on the ARTG. All manufacturers would continue to have the option of seeking TGA conformity assessment.


Appendix A - The Australian Dental Industry Association

Formed in 1925, ADIA is the peak national association representing the suppliers of quality dental product and services to dentists and allied oral healthcare professionals. The ADIA membership represents businesses that supply around more than ninety-five percent of the nation's purchases of dental product and consumables which are valued at an estimated $860 million per annum.

ADIA members have the opportunity to contribute to the development of not only the Association, but also the broader dental industry, through a number of national committees that address regulatory, technical, skills and industry promotional issues. A national board of seven leading professionals attends to governance matters and sets the strategic direction of the Association.

ADIA supports a regulatory framework for dental products and services that is based upon a risk-management approach designed to ensure public health and safety, while at the same time freeing business from an unnecessary regulatory burden. The Association provides advice to agencies including the TGA and the National e-Health Transition Authority (NeHTA), often nominating industry representatives to government committees and working groups. The Association also supports its members in the development of technical standards for dental products and consumables, nominating industry representatives to committees of both Standards Australia and the International Standards Organisation (ISO).

ADIA builds partnerships between dentists and the suppliers of dental products and services. The Association is the organiser of the nation's premier dental trade show, the highly acclaimed ADX Dental Exhibition, which attracts more than four thousand dentists and allied oral healthcare professionals every year.

At an international level, ADIA is a founding member of the International Dental Manufacturers (IDM), the Geneva-based global confederation of national dental trade associations. ADIA is also a supporting member of the World Dental Federation (Fr.

Federation Dentaire lnternationale- FDI).

Working with members to ensure that the dental industry has ongoing access to a workforce of skilled professionals, the Association supports the development of both TAFE and university courses relevant to the dental industry and the Association delivers the widely acclaimed AD/A Introduction To Dentistry Course.

The ADIA national office is based in Sydney and the Association is active in all mainland states.

More information can be found online at www . adia. org. au


Appendix 8 - Abbreviations

AD IA

AI MD

ANZTPA

CAB

DPP

EU

FDI

GHTF

IDM

IVD

IMDRF

MRA

TGA

Australian Dental Industry Association

Active Implantable Medical Device

Australia New Zealand Therapeutic Products Agency

Conformity Assessment Body I Bodies

Director of Public Prosecutions

European Union

World Dental Federation (Fr. Federation dentaire internationale)

Global Harmonisation Task Force

International Dental Manufactures association

In Vitro Diagnostics

International Medical Device Regulators Forum

Mutual Recognition Agreement

Therapeutic Goods Administration

proposal paper on changes to premarket assessment … · 2014-08-08 · tga medical device...

Documents