You are here

Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

Book pagination

Attachment G: Summary of consultation on Regulation Impact Statement exposure draft

The following summarises submissions made in response to the exposure draft RIS: Changes to premarket assessment requirements for medical devices. The paper was released on 10 May 2013, and was open for comment until 3 June 2013.

Option 1: No immediate action

Stakeholder Stakeholder comments TGA comments
Support
IVD Australia
  • This option preferred by most IVD sponsors.
  • The IVD sector would prefer to wait until EU framework and ANZTPA were established before progressing reforms.

Reforms already underway do address public health and safety. However postmarket changes do not address the concern that issues with implantable devices should be identified at premarket assessment where possible.

Undertaking these reforms does not preclude future reforms to focus the TGA's role to that of competent authority, however this option is not proposed at this time, given the proposed reforms proposed in the EU. The EU reforms will address assessment and oversight of competent bodies and notified bodies, to ensure appropriate consistency, accountability and role clarity. Until future arrangements are clear it would be premature for Australia to make parallel changes.

Medtronic Australasia Pty Ltd
  • Proposes a modified version of Option 1, also including shift of TGA role to competent authority to designate conformity assessment bodies (in line with the role of European member states)
  • Suggests full implementation of existing reforms are effective in increasing safety and performance, including:
    • increased post market surveillance, including devices registries for high risk devices,
    • reclassification of hip, knee and shoulder joint implants
    • confidence building with EU notified bodies
Medical Technology Association of Australia (MTAA)
  • Expresses concern that Option 1 is presented as a ‘do nothing' scenario, while the numerous reforms already underway are sufficient to address concerns (including reclassification of joint implants, registries, etc)
Medical Technology Association of New Zealand (MTANZ)
  • Would be supportive of Option 1 if it included the abolition of TGA conformity assessment requirements (Option 2 Proposal C).
  • Feels current arrangements provide sufficient premarket rigour, and resources would be better focussed on post market areas.
Not support
Australian Dental Industry Association (ADIA)
  • Agrees on balance that Option 1 should not be recommended, though notes Option 1 is the appropriate fall back from Option 2
  • Notes that post market scrutiny is an important component of effective device regulation

Along with a number of stakeholders, the TGA notes that post market scrutiny is a critical component of device regulation, and a number of reforms already underway address public health and safety.

However, concerns with the performance of some notified bodies pose unacceptable risks to Australian consumers for some higher risk medical devices. On this basis, additional premarket scrutiny of the assessment by a notifed body is warranted until confidence building activities are conducted.

BSI Medical Devices
  • The current regulatory system prevents Australian manufacturers selecting EU notified bodies for assessment
Consumer Health Forum of Australia (CHF)
  • Does not support Option 1 as it does not meet the key objective of the reform
Johnson & Johnson Medical Pty Ltd
  • Does not support Option 1
  • Notes that post market scrutiny is an important component of effective device regulation
Stryker Australia
  • While Stryker appear to support Option 2, their comments indicate that Option 1 is the appropriate fall back from Option 2
  • Notes that post market scrutiny is an important component of effective device regulation
William A Cook Australia Pty Ltd
  • Does not support Option 1
  • Notes that post market scrutiny is an important component of effective device regulation
No comment
Accord Australasia Limited
Australian Dental Association (ADA)
Friends of Science in Medicine
GS1 Australia
Johnson & Johnson Pacific Pty Ltd
M Engineering Australia Pty Ltd
National E-Health Transition Authority
ResMed Ltd
Mr Thomas Vreugdenburg- University of Adelaide
Name not to be published at submitters request
Name not to be published at submitters request

Top of page

Option 2: Changes to premarket assessment of medical devices: Proposal A

Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion, including:

  • Increase the number of products targeted for mandatory audits to include some Class IIb implantable and long term surgically invasive devices;
  • Introduce a new Level 3 audit to assess additional evidence of conformity for AIMD and Class III implantable medical devices together with a fee commensurate to the additional analysis required
Stakeholder Stakeholder comments TGA comments
Support
Australian Dental Association (ADA)
  • Qualified support
  • Appropriate to subject maxillofacial implants to application audits.
  • Application audit fees should represent a maximum amount and vary depending on the level of assessment undertaken.
Application audit fees relate to the actual costs incurred by TGA to undertake a consistent approach in application assessment. The audit level to apply for a given application is at TGA discretion; however indicative audit levels may be further consulted on with stakeholders.
BSI Medical Devices
  • General support for Option 2, although no direct comment on this element.
  • General comments include:
    • strong support for third party assessment bodies conducting conformity assessment
    • support for reducing audit levels based on confidence building for EU notified bodies
    • confidence building will allow TGA insight into international review of medical devices
Johnson & Johnson Medical Pty Ltd
  • Qualified support
  • Supports the list of devices subjected to mandatory audit and wishes for further consultation on this list and the level of audit for each device.
  • Concerns raised over significant regulatory burden associated with new devices subjected to mandatory audit and suggests mandatory audit timeframes to review application audits.
  • Concerns over subjecting Class IIb medical devices to an audit designed for Class III medical devices (i.e. providing design examination certificates).
  • Questions value in reviewing notified body audit report.
  • Concerned that documentation requirement for level 3 audits are still unclear.

Further consultation with industry is to occur on implementation, including the list of medical devices subjected to audit and their indicative level of audit.

The review of notified body assessments allows TGA to review raw clinical data underpinning the conformity assessment report rather than the clinical expert report (as is the case for Level 2 audits), as well as the design examination report (currently only viewed as part of a conformity assessment process, if available).

Johnson & Johnson Pacific Pty Ltd
  • States general support for Option 2, although no direct comment on this element.
M Engineering Australia Pty Ltd
  • General support for Option 2, although no direct comment on this element.
Stryker Australia
  • Supports increased assessment of long term implantable medical devices and grouping of application fees.
  • TGA could assume role of competent authority and not a third party assessment body.
Undertaking these reforms does not preclude future reforms to focus the TGA's role to that of competent authority, however this option is not proposed at this time, given the proposed reforms proposed in the EU.
William A Cook Australia Pty Ltd
  • Supports this proposal if implemented with option 2, proposal C.
  • Suggests creation of transparent guidelines on audit levels which also explains how the level of audit will be assigned.
  • Concern about the cost of audits - welcomes reduction of audit levels once confidence building occurs, and opportunity to group applications to reduce audit costs.
Not support
Consumer Health Forum of Australia
  • Urge reversal of this proposal to that presented in the January-March consultation paper to protect public health and safety.
  • All Class IIb medical devices should be audited.
  • Supports introduction of Level 3 audit.
The ability for the legislative instrument to be amended over time will better protect public health and safety through identifying and scrutinising devices that pose a risk to public health and safety. By using the legislative instrument to target Class IIb implantable medical devices of real risk, consumers can benefit from faster access to other devices not of concern. For example, there is little benefit in doing Level 2 audits for a dental implant.
Friends of Science in Medicine
  • Concerned none of the options outlined address increased premarket scrutiny for low risk medical devices.
  • Suggests reforms should remove ineffective low risk medical devices from the ARTG and prevent subsequent ARTG inclusion to protect vulnerable patients.
Although it would be ideal to focus reforms on efficacy of low risk medical devices, the significance of the problems faced by patients, health professionals and Governments when higher risk implantable devices fail requires immediate attention.
Medical Technology Association of Australia (MTAA)
  • MTAA challenges why AIMD and Class III medical devices need increased scrutiny
    • majority of recalls were identified through post market use and often for specific manufacturing issues such as labelling.
    • System for Australian Recalls Actions (SARA) database identified less than 8% recalls for Class III medical devices (0.3% of which were implantable Class III medical devices) and less than 1% were AIMDs.
    • SARA identified 0.5% of recalls were for Class IIb medical devices subjected to audit under Regulation 5.3, or suggested to be captured by application audit
  • Clear and transparent decision process is needed as to the reasons why devices are selected or unselected for mandatory audit. This rationale should be linked to post market.
  • The following post market mechanisms could be utilised to provide greater regulatory confidence:
    • Mandatory adverse event reporting
    • Mandatory annual reporting for Class IIb implantable, AIMD and Class III medical devices
    • TGA statutory advisory committees
    • Clinical registries
    • International vigilance exchange
  • Provided detailed costing data to compare to TGA data.
    • Advised that the average cost of obtaining a design examination report from the notified body is $10,000 (required for all AIMD and Class III medical devices).
  • Suggests shift of TGA role to competent authority to designate conformity assessment bodies (in line with the role of European member states)

Undertaking these reforms does not preclude future reforms to focus the TGA's role to that of competent authority, however this option is not proposed at this time, given the proposed reforms proposed in the EU.

There are concerns about the cost of obtaining design examination report from the notified body, however applications for ARTG inclusion already include a declaration that this is information is available, either because the sponsor has it or can access it in a timely manner.

Medical Technology Association of New Zealand (MTANZ)
  • No evidence that the reforms increase rigour and safety of premarket assessment of medical devices.
  • This proposal will delay products to market and increase compliance costs.
  • European reforms will do more to improve safety of medical devices than this proposal.
  • Supports reduction of audit once confidence building has occurred.
  • Option 2 will add an estimated $6 million AUD to the cost of medical device inclusion in Australia.
  • Many New Zealand stakeholders need to develop documentation to comply with this requirement, a cost estimated at $10,000 AUD per device.

EU reforms will assist in improve safety of medical devices, however the EU reforms are expected to take some time to agree and implement (currently estimated to come into effect around 2020). This reform package, together with other reforms such as confidence building in EU notified bodies and post market reforms, will address concerns in a more timely manner, and are consistent with proposed EU reform package.

Note that many New Zealand manufacturers and sponsors will already hold appropriate conformity assessment document if they currently supply to regulated markets, including the EU and Australia (typically from EU notified bodies).

Medtronic Australasia Pty Ltd
  • Estimates increase in Medtronic direct costs is $530,000 (290%) per annum.
  • Concerns this proposal will increase in the time to market for medical devices, duplicate EU regulatory scrutiny, and that additional premarket scrutiny is not warranted.
  • Grouping of application fees should relate directly to the amount of work undertaken.
  • Regular reviews of the legislative instrument and Regulation 5.3 need to be conducted to ensure currency.
  • Suggests shift of TGA role to competent authority to designate conformity assessment bodies (in line with the role of European member states)
Undertaking Option 2 reforms does not preclude future reforms to focus the TGA's role to that of competent authority, however this option is not proposed at this time, given the proposed reforms proposed in the EU.
Name not to be published at submitters request
  • Generally supports Option 2, but does not support this aspect of Option 2 as presented, as it is concerned dental implants may still be captured under this proposal.
  • Concerned that dental implants should be excluded for mandatory audit until TGA establishes a need for inclusion, and imposing mandatory audits may increase regulatory costs by 378%.
  • Concerns over implementation of a legislative instrument and suggests creation of a guidance document to explain the use of this instrument.
Option 2 allows for identification of Class IIb implantable devices subject to mandatory audit, providing flexibility to exclude dental implants if no risks to safety are identified. Further consultation with industry is to occur on the list of medical devices subjected to audit and their indicative level of audit. However it is not generally intended that dental implants would be audited, given that they are more readily removed than other implanted medical devices should post market issues arise.
Name not to be published at submitters request
  • Generally supports Option 2, but does not support this aspect of Option 2 as presented, as it is concerned dental implants may still be captured under this proposal.
  • Concerned that dental implants should be excluded for mandatory audit until TGA establishes a need for inclusion, and imposing mandatory audits may increase regulatory costs by 378%.
  • Concerns over implementation of a legislative instrument and suggests creation of a guidance document to explain the use of this instrument.
Option 2 allows for identification of Class IIb implantable devices subject to mandatory audit, providing flexibility to exclude dental implants if no risks to safety are identified. Further consultation with industry is to occur on the list of medical devices subjected to audit and their indicative level of audit. However it is not generally intended that dental implants would be audited, given that they are more readily removed than other implanted medical devices should post market issues arise.
No comment
Accord Australasia Limited
  • Members not affected by the proposal therefore no comment provided.
Friends of Science in Medicine
GS1 Australia
IVD Australia
  • Not affected by the proposal therefore no comment provided.
National E-Health Transition Authority
  • No direct comment on Options.
  • Recommends using GS1 products to assist in identification, procurement, invoicing, and standardisation of data.
ResMed Ltd
  • Not affected by the proposal therefore commented the level of scrutiny for ‘medium risk' devices is appropriate.
Mr Thomas Vreugdenburg- University of Adelaide
  • Conducted a study with participants from the breast cancer community.
  • No comment from 16 stakeholders from breast cancer community, however general comments include:
    • Suggests quality assurance to ensure risk classification of medical devices is correct and represents the actual use in the community – notes classification based on ‘intended purpose' rather than the uses in practice.

Top of page

Option 2: Changes to premarket assessment of medical devices: Proposal B

Proposal B: Publication of medical device regulatory decisions (including IVDs)

Stakeholder Stakeholder comments TGA comments
Support
Australian Dental Industry Association (ADIA)
  • Qualified support
  • Need further consultation on implementation to address ongoing concern about:
    • possible release of confidential information
    • potential damage to manufacturer and/or sponsor reputation through misinformation or misrepresentation (especially for rejected applications)

Further consultation with stakeholders may occur to discuss implementation of this proposal and development of the AusPAR like format. This will need to address the appropriate scope of the document, treatment of confidential information, etc.

Publication of unsuccessful decisions is a vital element to ensure transparency of the regulatory process and not just transparency of the end result of this process (ARTG inclusion). As outlined above, this proposal has been modified so that only rejections relating to safety and/or efficacy of medical devices would be published, so that negative decisions with public health implications are transparent.

BSI Medical Devices
  • General support for Option 2, although no direct comment on this element.
Consumer Health Forum of Australia (CHF)
  • Supports publication of decisions for all medical devices:
    • Conformity assessment and ARTG applications for all classes of applications, whether successful or unsuccessful
    • Implemented at the same time rather than staggered as suggested in the proposal.
Johnson & Johnson Medical Pty Ltd
  • Qualified support:
    • Suggests only publishing successful applications for high risk devices (AIMD, Class III and Class IIb devices encompassed under Option 2, proposal A).
    • Questions value in publishing AusPAR like document for automatically included ARTG entries (i.e. Class I medical devices).
    • Do not support publication of unsuccessful medical device decisions.
Johnson & Johnson Pacific Pty Ltd
  • Qualified support:
    • Limit to successful applications for high risk products
    • Do not publish decisions on low risk devices or those rejected for ARTG inclusion
M Engineering Australia Pty Ltd
  • States support for Option 2 without further comment.
Medical Technology Association of Australia (MTAA)
  • Qualified support:
    • further stakeholder consultation is required to target the appropriate audience and their documentation requirements.
    • A document extensive as an AusPAR may not be required for medical device decisions.
    • Publication of decision should not be funded by industry (not be cost recovered).
  • Provided detailed costs analysis to compare to TGA costings.
Medical Technology Association of New Zealand (MTANZ)
  • Qualified support:
    • Further consultation required on implementation
    • Supports staged implementation of publication of decisions.
    • Expects costs for this proposal to be carried by TGA and not industry.
Medtronic Australasia Pty Ltd
  • Qualified support:
    • Subject to costs and other concerns raised in previous consultation round
    • Previous submission indicated need to ensure basis of the decisions are transparent, evidence considered in reaching decisions is outlined, no confidential information is released, and to cover new inclusion only
ResMed Ltd
  • Qualified support - suggest the following not be included:
    • conformity assessment decisions (no benefit to public as this does not enable supply)
    • Class IIa applications or Class IIb applications not audited (based on ‘kind of device – no benefit to public)
    • device information (instructions for use, etc) for Class IIa or IIb - included as kind of device - specific to models rather than ARTG entry
    • rejected decisions
Mr Thomas Vreugdenburg- University of Adelaide
  • Support:
    • Welcome increased accessibility of information and transparency of TGA processes (though perhaps of more value to consumer advocates than directly for consumers)
    • Some concern about cost
    • Support publication for all devices (including low risk) and rejected decisions
William A Cook Australia Pty Ltd
  • Support:
    • need further consultation on implementation
    • suggest liaising with sponsor before release of information.
    • minimise provision of additional information not currently provided to TGA
    • note 'kind of device' limits impact of proposal (would not support additional reporting to change this)
Name not to be published at submitters request
  • Qualified support - limit to positive decisions only.
  • If negative decisions are included, this should be limited to rejections due to safety and/or efficacy reasons (aligned to arrangements for publication of medicines decisions)
Name not to be published at submitters request
  • Qualified support - limit to positive decisions only
  • If negative decisions are included, this should be limited to rejections due to safety and/or efficacy reasons (aligned to arrangements for publication of medicines decisions)
Not support
Accord Australasia Limited
  • Not opposed to publication of some decisions, however significant concerns about the scope and implementation:
    • exclude low risk and unsuccessful applications
    • RIS does not include sufficient cost benefit analysis eg $528 cost per decision is not justified for low risk medical devices,
    • Cost should have been considered based on difference in risk/benefit scenarios rather than complexity of decision making. i.e. publishing a high risk medical device decision is more beneficial to the public
  • TGA should reconsider the different options for publishing medical device decisions.
TGA costs for processing medical device applications is based on risk, which is evident in the level of assessment fee and annual charge dependent on the class of medical device. As publishing decisions is documenting a process, a risk/benefit approach does not need to be taken when costing this aspect of Option 2.
IVD Australia
  • Supportive of Option 2 as a whole but strongly opposed to this proposal.
  • Concerned that TGA did not appear to cost publication of IVD products, as an additional 100 complex decisions a year could be for Class 3 and Class 4 IVDs and an additional 200 'simple decisions'. This will add $150,000/ year to include IVD products in the ARTG (these costs are in addition to the current IVD framework).
  • Supportive of publication of decisions if the information provides public benefit, is factually accurate, not commercial in-confidence and presents little/no regulatory burden on manufacturers.
  • Concerns over how and what information is to be published and why TGA continue to propose publication of unsuccessful conformity assessment decisions.
  • Does not support publication of unsuccessful decisions, conformity assessment decisions, and decisions for a 'kind of medical device'.
  • Unclear of how publication will occur for a 'kind of medical device' that are included under a single ARTG entry.
  • Reference should be made to Canadian CMDCAS Registrars as well as European notified bodies.
No comment
Australian Dental Association (ADA)
Friends of Science in Medicine
GS1 Australia
National E-Health Transition Authority (NeHTA)
Stryker Australia

Top of page

Option 2: Changes to premarket assessment of medical devices: Proposal C

Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of all medical devices except Class 4 IVDs

Stakeholder Stakeholder comments TGA comments
Support
Accord Australasia Limited
  • Strongly support without further comment.
Australian Dental Industry Association (ADIA)
  • Support
BSI Medical Devices
  • Support
Name not to be published at submitters request
  • Support
Name not to be published at submitters request
  • Support
IVD Australia
  • Qualified support:
    • Supportive as provides benefit for manufacturers of Class 2 and Class 3 IVDs but concerned manufacturers of Class 4 IVDs disadvantaged.
  • Suggest aligning Australian conformity assessment regulations with EU regulations in the future.
  • States that the benefit of undertaking third party conformity assessment far outweighed by other costs in Option 2.
Johnson & Johnson Medical Pty Ltd
  • Support
Johnson & Johnson Pacific Pty Ltd
  • Support
M Engineering Australia Pty Ltd
  • Generally supportive of Option 2 (no specific comment on this element)
  • Concerned the lack of third party assessment bodies in Australia impedes local medical device industry development - especially to small companies.
Australian manufacturers can still choose to use TGA conformity assessment, but also have the option to choose overseas third party assessments.
Medical Technology Association of Australia (MTAA)
  • Support
  • Questions why Australian manufacturers of Class 4 IVDs are excluded.
  • Suggest implementation independently of Option 2, Proposal A.
  • Estimates two thirds of Australian manufacturers would not continue with TGA conformity assessment.
Medical Technology Association of New Zealand (MTANZ)
  • Support
  • Suggest implementation independently of Option 2, Proposal A.
Medtronic Australasia Pty Ltd
  • Support
  • Suggests removal of all requirements for TGA conformity assessment (including under Regulation 5.3), and shift of TGA to role of competent authority
Undertaking Option 2 reforms does not preclude future reforms to focus the TGA's role to that of competent authority, however this option is not proposed at this time, given the proposed reforms proposed in the EU.
ResMed Ltd
  • Support
  • Some queries about implementation details
  • Prefer for notified bodies to be accredited to issue conformity assessment under Australian arrangements (rather than just allowing use of EU conformity assessment) as this may impact entry to a number of Asia Pacific and Latin American markets (require home country approvals)
The use of EC certificates to be similar to the current process used for medical devices not manufactured in Australia. Applications for ARTG inclusion will be submitted with the EC certificate attached and the device may be selected for audit (mandatory under Regulation 5.3, or non mandatory) or approved within 20 days of submission. This process will be further refined during consultation with stakeholders on this specific issue.
Stryker Australia
  • Generally supportive of Option 2 (no specific comment on this element)
Mr Thomas Vreugdenburg- University of Adelaide
  • Qualified support:
    • rigorous quality assurance still required
    • need to consider Australian context impacting effectiveness of device in operation in Australia
    • may create difficulties for publication of decisions (lack of information)
80% of medical devices are already approved in Australia using EU EC certificates as evidence of conformity assessment.
William A Cook Australia Pty Ltd
  • Strongly support
Name not to be published at submitters request
  • Support
Name not to be published at submitters request
  • Support
Not support
Consumer Health Forum of Australia (CHF)
  • Do not support:
    • particularly concerned about conformity assessment of some EU notified body, and this expands exposure of Australian consumers to these risks
80% of medical devices are already approved in Australia using EU certificates as evidence of conformity assessment. Confidence building, and audits under Option 2 Proposal A, provide greater assurance in EU conformity assessment certification.
No comment
Australian Dental Association (ADA)
Friends of Science in Medicine
GS1 Australia
National E-Health Transition Authority (NeHTA)

Top of page

Option 3 - Expand TGA mandatory conformity assessment for AIMD and Class III implantable medical devices and allow third party conformity assessment for other devices except Class 4 IVDs

stakeholder3 stakeholder3 comments TGA comments
Support
     
Not supported
Australian Dental Industry Association (ADIA)
  • Does not support this option
BSI Medical Devices
  • Does not support this option
  • TGA could better utilise knowledge in EU notified bodies.
Consumer Health Forum of Australia (CHF)
  • Does not support this option
IVD Australia
  • Does not support this option
  • States that this Option provides a more streamlined process than Option 2.
Johnson & Johnson Medical Pty Ltd
  • Does not support this option
Medical Technology Association of Australia (MTAA)
  • Does not support this option
Medical Technology Association of New Zealand (MTANZ)
  • Does not support this option
Medtronic Australasia Pty Ltd
  • Does not support this option
Stryker Australia
  • Does not support this option
William A Cook Australia Pty Ltd
  • Does not support this option
No comment
Accord Australasia Limited
Australian Dental Association (ADA)
Friends of Science in Medicine
GS1 Australia
Johnson & Johnson Pacific Pty Ltd
M Engineering Australia Pty Ltd
National E-Health Transition Authority (NeHTA)
ResMed Ltd
Mr Thomas Vreugdenburg- University of Adelaide
Name not to be published at submitters request
Name not to be published at submitters request

Other issues:

  • MTAA - increased post market scrutiny will provide stronger protection of the public's health and safety.
  • IVD Australia
    • Australian market for IVDs is $1 billion and the world market is around $50-55 billion, therefore Australian IVD market is 2% or less.
    • Implementation and review do not seem to take into account the "Proposed Changes to the IVD Framework"

Top of page

Book pagination