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

26 June 2013

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Options

Three options being considered in this RIS respond to the concerns above and are outlined below:

  1. Take no immediate action to change premarket assessment requirements for medical devices
  2. Change the premarket assessment of medical devices through:
    1. increased scrutiny of conformity assessment for higher risk medical devices as part of mandatory application audits prior to ARTG inclusion
    2. publication of information about TGA regulatory decisions (including IVDs)
    3. abolition of the requirement for TGA conformity assessment for Australian manufacturers (excluding manufacturers of Class 4 IVDs)
  3. Expand TGA mandatory conformity assessment for AIMD and Class III implantable medical devices and allow third party conformity assessment for other devices (other than Class 4 IVDs).

Option 1 - No immediate action

This option would require no change to current arrangements.

Existing arrangements are sufficient

Some respondents to the most recent consultation suggested that premarket scrutiny of medical devices has already been substantially enhanced by the reclassification of hip, knee and shoulder joint implants from 1 July 2012. It was also argued that this reclassification, balanced with pre and post market monitoring through a number of existing mechanisms within the regulatory framework are a sufficient increase in scrutiny of higher risk devices early in their market life. These monitoring mechanisms include:

  • Annual reporting: Sponsors are already required to provide annual reports to the TGA on high risk devices during the first three years of ARTG inclusion, thereby providing an early warning system once a device is used in or on patients
  • TGA statutory advisory committees: These committees provide independent expert advice to the TGA , with both a pre and post market focus
  • Clinical registries: There are currently some clinical registries established to assist in postmarket surveillance and in the 2013-14 Budget the Government committed to increasing the number of these to allow the safety and quality of healthcare delivered to patients to be tracked23
  • International vigilance exchange: Through the IMDRF exchanges of surveillance information provide participating countries (including Australia) with knowledge of problems being experienced in other nations, providing for timely corrective action to be undertaken.

However, the difficulties of relying on postmarket mechanisms have been detailed above in the 'Problem' section.

International regulatory changes

In response to the recent consultation, some stakeholders also argued that it would be premature for Australia to undertake regulatory changes beyond those that have already occurred, until the reform activities in the EU are completed, to ensure the systems remain aligned. Additionally, it was argued that until transition to the joint regulatory agency with New Zealand should be completed changes to premarket requirements will make it difficult for New Zealand manufacturers to transition to the joint agency.

As a result, one option would be to delay making changes to the Australian regulatory framework until the international environment is clarified and developments in Europe are finalised and implemented (approximately 2020). After that time changes would be made to align them to and/or build on those changes for implementation in Australia and New Zealand under the ANZTPA.

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Assessment of this option against the objectives

This option does not meet the key objective of the reforms - i.e greater assurance that higher risk medical devices approved do not compromise public health and safety. This is because it does not enhance premarket scrutiny of higher risk devices over the status quo, and does not allow the TGA to form an independent opinion of whether the Essential Principles for quality, safety and performance have been met. This option also does not focus on increasing efforts to reduce the risk of device failures occurring in the first place, particularly for implantable medical devices.

TGA has been developing options for increasing premarket scrutiny of higher risk medical devices for a number of years, dating back to consultations in December 2008. Additionally, the HTA Review in late 2009 and the two Senate inquiries in 2011 and 2012 reaffirmed the need for increased premarket scrutiny.

Again, waiting for the EU to reform its framework and the resulting uncertainty (possibly until 2020) is not appropriate given the significance of the problems faced by patients, health professionals and Governments when higher risk implantable devices fail.

Additionally, this option does not improve TGA's ability to target emerging risks appropriately as it does not facilitate a higher level of review to be undertaken where the need is identified. Finally, this Option also does not address the issues identified in Europe in relation to the oversight of the notified bodies and is therefore at odds with the direction being set by the European Commission.

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Option 2 - Changes to premarket assessment of medical devices

This option proposes:

  • Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion, through
    • increasing the number of products targeted for mandatory audits to include selected Class IIb implantable and long term surgically invasive devices
    • introducing a new Level 3 audit to assess additional evidence of conformity for AIMD and Class III implantable and long term surgically invasive medical devices together with a fee commensurate to the additional analysis required
  • Proposal B: Publication of medical device regulatory decisions (including IVDs)
  • Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of all medical devices except Class 4 IVDs.

Please note that Proposals A and C are intended to operate together as a package, because in this way the level of risk for higher risk medical devices produced by Australian manufacturers in not increased through the removal of TGA conformity assessment for these manufacturers. However, it is possible to implement Proposal B in isolation from the other proposals in this option.

Proposal A: Increased scrutiny of conformity assessment

This proposal would expand the range of products subject to mandatory audits by the TGA for medical devices (excluding IVDs at this stage given the IVD transition is continuing).

The elements of this proposal are:

  • Expanded range of products subject to mandatory audits: The requirement for a mandatory audit of an application would be extended to cover specific implantable and long term surgically invasive Class IIb medical devices (in addition to those kinds of devices currently referred to in Regulation 5.3).
  • Assessment of evidence of conformity: Using existing powers, the TGA would introduce a new ‘Level 3’ audit for AIMD and Class III implantable and surgically invasive medical devices, to more closely review existing conformity assessment information relating to the device. This may involve review of the raw clinical data underpinning the conformity assessment report rather than the expert clinical report as occurs for the Level 2 audit, the Notified Body's Design Examination report, and a desk audit of the manufacturer’s quality management system. This element would include introduction of a new level of application audit fee (a 'Level 3' audit, to be added to the existing 'Level 1' and 'Level 2' audits) to reflect the greater depth of analysis undertaken for those higher risk devices.
Expanded targeting of mandatory audits

The mandatory audit changes are no longer intended to capture all Class IIb implantable and long term surgically invasive medical devices as was proposed in the January to March 2013 consultation document. As a result of that consultation the intention is to identify those Class IIb devices required for mandatory audit by the perceived and/or demonstrated level of risk associated with the product. This would be achieved by creating an instrument to identify these medical devices, rather than prescribing the mandatory audit requirements directly in the regulations. The advantage of this approach is that devices can be added and removed more readily to reflect emerging issues (or their resolution).

Devices could be added to or removed from this legislative instrument24 based on an assessment of the perceived and/or demonstrated level of risk. At this stage, it is anticipated that the list would be populated with:

  • Surgically invasive and/or long term implantable medical devices: Focusing on implantable and surgically invasive Class IIb devices of particular concern as opposed to capturing all Class IIb implantable devices for mandatory audit (noting that AIMD and Class III medical devices are already captured under existing mandatory audit arrangements). Most of the Class IIb implantable devices intended to be selected for mandatory audit outlined in Table 1 below are those where removal of the device would be significantly problematic for the patient (such as spinal fixation devices which are intended to maintain the integrity of the spinal column). Narrowing the list of implantable Class IIb products to be captured for mandatory audit as per those in Table 1 is based on feedback received during the January to March 2013 consultation process which indicated that a greater level of scrutiny through mandatory audit was not warranted for a number of surgically invasive and/or long term implantable devices. The revised proposal now excludes dental implants from mandatory audit requirements
  • New and novel technology: Where a new and novel technology is likely to have a significant impact on public health or where the risks have not been widely established (Class IIb and above). Table 1 below does not yet contain any of these devices but it is intended that the types of devices that should be included will be the subject of implementation consultation
  • Post market issues: Where devices are experiencing post market issues of concern (Class IIb and above). The one type of device included on the list below on the basis of postmarket problems are the surgical mesh implants. Other medical devices may need to be included but will be the subject of implementation consultation.

The Class IIb devices outlined above can currently be audited on a discretionary basis where concerns arise relating to their application, but this only occurs where the TGA has concerns. Mandatory auditing means the TGA will systematically look at applications for all these medical devices in more detail before they can be approved for inclusion in the ARTG, examining information which is not routinely provided by sponsors in their applications. Mandatory audits also attract a fee, while discretionary audits do not.

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Table 1 below provides an indication of Class IIb devices to be captured for audit, and the level of audit which would normally be expected (but will not always apply)25. The contents of this list would be subject to further consultation with stakeholders during the implementation process. As noted above, the list below does not include devices that are new or novel technologies.

Table 1: Class IIb medical devices proposed to be subject to mandatory audit
Device Expected Audit Level
Spinal fixation devices Level 2 audit
Orthopaedic fixation devices Level 1 audit
Bone screws, plates, pins and wires Level 1 audit
Finger, wrist and ankle joint prostheses Level 1 audit
Artificial bone matrix implants Level 1 audit
Non-absorbable implants such as sutures, staples and anchors Level 1 audit
Surgical mesh Level 2 audit
Long-term invasive vascular access devices, such as implantable ports Level 1 audit
Maxillofacial implants Level 1 audit
Peripheral vascular stents, biliary stents etc. Level 2 audit
Shunts, such as portacaval shunts Level 1 audit
Long term implantable devices used in bariatric surgery Level 2 audit
Systems and procedure packs containing any of the above devices Audit level in line with the highest audit level of the contents of the system or procedure pack

Existing mandatory audit requirements as outlined in Regulation 5.3 would also continue (with the following list also indicating the level of audit normally anticipated for these medical devices):

Table 2: Expected audit levels for Class III medical devices (already subject to mandatory audit)
Device Expected Audit Level
Barrier contraceptives (other than condoms) Level 1 audit
Implantable contraceptive devices Level 2 audit
Medical devices that are specifically intended by the manufacturer to be used for disinfecting another medical device Level 1 audits for hardware devices i.e. autoclave, and Level 2 audits for disinfecting agents i.e. liquid disinfectants to disinfect other medical devices
Implantable intra-ocular lenses Level 1 audit for posterior lenses and Level 2 audits for other lenses
Intra-ocular visco-elastic fluids Level 2 audit
Class III and AIMD medical devices not supported by conformity assessment issued by the TGA or issued under the EU MRA Level 3 audit for targeted devices only (AIMD, implantable and surgically invasive), Level 2 audit for other Class III medical devices

The only change to the list above arising from the consultations relates to the level of audit for medical devices intended to disinfect another medical device. Advice received, and subsequently confirmed within the TGA, indicates that a Level 1 audit is suitable for hardware devices but a Level 2 audit remains appropriate for liquid disinfectants.

It should be noted that Subregulation 4.1(2), which prescribes the kinds of medical devices that require a TGA conformity assessment will be retained.

Assessment of evidence of conformity and new audit fee

Proposal A would also introduce a Level 3 audit for new applications together with a new fee commensurate with the additional analysis required. As is currently the case for the existing audit program, the level of audit to be applied in relation to any particular application would be at TGA's discretion in the particular case. Discretion is necessary as the reasons for selecting particular audit levels do not only relate to the nature of the device itself, but may also reflect concerns about the particular application such as the information included with the application, the quality of the clinical evidence etc. A list of the indicative audit levels would be provided as a guide to industry in anticipating application costs and, to some extent, timeframes. An indication of those audit levels is included above.

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The following table outlines the documents assessed for the existing Level 1 and Level 2 audits, and the proposed additions for Level 3 audits (with additional documents for each progressive audit level highlighted in bolded text):

Table 3: ARTG application audits - maximum level of assessment
Level 1 audit Level 2 audit Level 3 audit

Declaration of Conformity

Conformity assessment evidence

Information about the device (label, instructions for use, advertising materials)

Declaration of Conformity

Conformity assessment evidence

Information about the device (label, instructions for use, advertising materials)

Risk management report

Clinical evaluation report

Efficacy and performance data (for medical devices that disinfect)

Declaration of Conformity

Conformity assessment evidence

Information about the device (label, instructions for use, advertising materials)

Risk management report

Clinical evaluation report

Efficacy and performance data (for medical devices that disinfect)

Design Examination report

Raw clinical data (underpinning the clinical evaluation report of the conformity assessment)

Desk audit of the Quality Management System (QMS)

Target Timeframe: 30 days Target Timeframe: 60 days Target Timeframe: Subject to implementation consultation (between 60 days which applies for a Level 2 audit and 255 days which applies for conformity assessment)

The cost of the Level 3 audit is estimated to be $16,382 ($10,212 of additional assessment plus the existing $6,170 Level 2 fee). This is outlined in detail in the 'Costs and benefits' section below.

Under a Level 3 audit, it is intended that the TGA would review information produced by a European notified body as part of the conformity assessment process. It is already expected that sponsors and manufacturers have access to this information (or have arrangements in place to access this information) to assure themselves that the declaration made by the sponsor at the time it makes an application for inclusion in the ARTG that the Essential Principles for quality, safety and efficacy have been met is accurate.

It is expected that Level 3 audits would primarily be undertaken on AIMD and Class III medical devices, as design examination reports are only available for these devices. If undertaken for lower Class devices, only the applicable components of the audit would be undertaken. The fees to apply for Level 3 audits will need to be resolved in preparing the Cost Recovery Impact Statement (CRIS) for these reforms. However, it is anticipated that the fee would be adjusted where only some components of the Level 3 audit are undertaken.

The outcome of confidence building with the EU to be conducted in 2013 and 2014 will be another factor in deciding the mandatory audit level. For example where conformity assessment has been issued by a notified body which has satisfied confidence building requirements, the level of mandatory audit could be reduced below Level 3.

This proposal would be fundamental in TGA building and maintaining an effective and efficient confidence building system that is embedded into its business as usual. It provides a process for reviewing the work already conducted by a notified body on an ongoing basis. While it may be more resource intensive in the short-medium term, as confidence building becomes established, the level of TGA oversight of assessments conducted by European notified bodies could reduce.

Grouping of application audits

In order to reduce costs to the medical device industry, grouping of applications for related medical devices may occur. This could reduce audit fees by 28 per cent where the following elements are the same: classification, manufacturer, level of audit, Global Medical Device Nomenclature (GMDN) code; AND where the application fee for all applications to be grouped is paid on the same day, with a letter attached to the application requesting a grouping and fee reduction.

What changes were made after the January 2013 consultation?

The RIS exposure draft released in May 2013 proposed modifications to Proposal A relating to the increased premarket scrutiny in the January 2013 consultation paper. The scope of mandatory audits was narrowed to certain subsets of higher Class IIb implantable and surgically invasive medical devices as well as other devices based on perceived or proven level of risk (i.e novel technologies or devices experiencing significant postmarket issues). Additionally the RIS exposure draft introduced the concept of an instrument to replace the current regulatory provisions relating to which products are subject to mandatory audit requirements. As amending a legislative instrument is easier that amending Regulations this would provide greater flexibility to respond to emerging issues with medical devices, and for the targeting of mandatory audits to be adjusted over time once the concerns are resolved or addressed.

How has this proposal changed since the May 2013 consultation?

The proposal in this RIS has not changed since the May 2013 consultation, and remains the same as that proposed in the RIS exposure draft.

Feedback from non-industry stakeholders, particularly from the Consumers’ Health Forum, indicated that narrowing the scope of products to just some surgically invasive and implantable Class IIb medical devices was inappropriate. However, the TGA considers that the narrower proposal captures the devices of greater risk, and offers a more refined and appropriate risk based approach. As the list of affected devices is proposed to be described in a legislative instrument, should any of the Class IIb implantable devices no longer captured due to the narrowing of the proposal demonstrate a need for additional review, they can relatively easily be added to the instrument.

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Proposal B - Publication of information about regulatory decisions

This proposal would involve publishing information on positive and negative regulatory decisions made by the TGA about ARTG inclusions and conformity assessment applications for medical devices and IVDs. The format for publishing all medical devices decisions will assume a format similar to the AusPAR (Australian Public Assessment Reports for prescription medicines).

An AusPAR is compiled by the TGA after the delegate has made a decision relating to the submission for new prescription medicines and major changes to existing prescription medicines. The draft AusPAR containing information on quality, safety, efficacy, pharmacovigilance26 and risks and benefits is forwarded to the sponsor for review of commercially confidential information.

Health Canada provides a document for medical devices covering similar information to the AusPAR but to a lesser extent. Canadian decision publications include information on the medical device, its safety and effectiveness, risk benefit assessment and the decision.27

However, the final format would be developed after further consultation with stakeholders, to ensure TGA provides appropriate information about decision making to the Australian public, while also considering industry confidentiality requirements. The timing of the publication of information about particular decisions will also need to be considered carefully, to take into account the rights of unsuccessful applicants to seek internal and Administrative Appeals Tribunal review of decisions. This proposal also provides an opportunity for the TGA to progress TGA Blueprint reform Proposal 4 - publication of medical device information - through publishing information supplied with the device such as instructions for use or labelling of a product as available at the time of application for ARTG inclusion. This published information will be directed to both health professionals and consumers to improve transparency of medical device information.

What changes were made after the January 2013 consultation?

The January 2013 consultation paper proposed publication of the TGA’s decision letter as a 'first step' towards an AusPAR equivalent. Following the feedback to the January 2013 consultation paper, this proposal was amended in the RIS exposure draft to publishing an AusPAR equivalent document rather than the TGA decision letter. This addressed concerns raised in consultation regarding appropriate confidentiality of commercial information providing advantages to competitors and consultation prior to publication as the AusPAR process takes all these elements into account.

Additionally, the January 2013 consultation identified broad in-principle support for the proposal to publish medical device decisions, but highlighted industry stakeholder concerns particularly on the publication of conformity assessment decisions or negative decisions.

These concerns were also expressed during the consultation prior to the introduction of AusPARs, although the Medical Technology Association of Australia (MTAA) submission to the January 2013 consultation noted that these issues had been anticipated but were largely not manifested in relation to publication of prescription medicine information28.

How has this proposal changed since the May 2013 consultation?

The proposal outlined in this RIS has been modified to publish negative decisions relating to ARTG inclusion and conformity assessment only where the reason for rejection relates to the safety and/or efficacy of the medical device rather than all negative decisions as this is the information of relevance to consumers, health practitioners and Government.

This modification has been made because concern was expressed, particularly during the May 2013 consultation, that the publication of negative decisions (rejecting an application for inclusion in the ARTG or a conformity assessment certification) would unduly prejudice public opinion against affected medical devices. On this basis, a number of submissions requested that, if negative decisions are to be published, this should be limited to negative decisions based on issues of safety and/or efficacy.

A number of other concerns were raised including avoiding delays of product entry in the ARTG and how the cost of this proposal may be passed on to the industry. These would need to be addressed in consultation with stakeholders in developing implementation arrangements.

Implementation is proposed to occur in stages, focusing first on higher risk medical devices, given the greater inherent risks associated with those devices. Further details are contained in the 'Implementation and review' section of this document. Proposed implementation arrangements have also been amended, to focus on publication of positive decisions first. This is to ensure industry confidence that appropriate processes are in place before the publication of negative decisions proceeds.

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Proposal C - Removing the requirement for TGA conformity assessment for Australian manufacturers except for Class 4 IVDs

This proposal abolishes the requirement for Australian manufacturers of medical devices to have TGA conformity assessment for all medical devices (except for Class 4 IVDs).

Under this proposal, the outcome would be that, except for Class 4 IVDs, an Australian manufacturer could choose to have their conformity assessment certificates issued by a European notified body rather than being limited to using the TGA. This provides for the TGA to more closely align the level of assessment to the risk of the device.

Class 4 IVDs will be excluded from this proposal until the European reforms to adopt the GHTF model for IVD regulation come into force. At this stage, the regulatory and evidentiary requirements for IVDs classified as Class 4 are higher in Australia than for the same devices in Europe. It is therefore not appropriate to accept European certification at this stage. This is particularly so as Class 4 IVDs are those which pose a high level of risk to public health if they do not perform as intended, and they therefore warrant an appropriate level of assessment.29

Given the large number of notified bodies in existence, it is not anticipated that there will be any reduction in the capacity to provide assessments for manufacturers previously using TGA conformity assessment. Manufacturers will also continue to have the option of seeking conformity assessment from the TGA.

Proposal A above, combined with the international confidence building activities that are currently in train between Australia and the EU, provides a mechanism for the TGA to refine and better target the management of risks around a particular type of device or a notified body rather than on the location of the manufacturer. This is because devices perceived or proven to be of risk will be selected for mandatory audit under Proposal A, with the TGA being able to review the full details of the conformity assessment conducted by a European notified body under a Level 3 audit until confidence building has occurred. Thereafter, TGA would be able to reduce its level of audit to Level 1 or 2 as necessary.

Additionally, providing TGA discretion to react to a suspected or proven risk rather than a blanket approach to regulation is consistent with its risk based approach to regulation. This also allows the TGA to deal with the increased workload associated with the implementation of Proposals A and B above.

What changes were made after the January 2013 consultation?

The January 2013 proposal was limited to allowing third party conformity assessment for Australian manufacturers for lower class devices (Class IIb and lower) only. Following feedback received, in the RIS exposure draft released in May 2013, the TGA expanded the proposal to cover all medical devices produced by Australian manufacturers except Class 4 IVDs.

During the January 2013 consultation, the proposal to expand the current arrangements for Australian manufacturers to lower risk medical devices and IVDs received overwhelming support from the majority of stakeholders. The majority of comments suggested extending the abolition of TGA conformity assessment for Australian manufacturers of Class III (high risk) medical devices. Additionally, the New Zealand medical device industry had expressed concern about the existing requirement for TGA conformity assessment for all Australian manufacturers being expanded to include New Zealand manufacturers under the ANZTPA arrangements, meaning that devices manufactured in New Zealand would not be able to be supplied under a joint regulatory scheme until reviewed by ANZTPA. Abolishing this requirement would address those concerns.

How has this proposal changed since the May 2013 consultation?

No additional changes are proposed following the RIS exposure draft consultation undertaken in May and June 2013. The proposal still seeks to abolish the requirement for TGA conformity assessment for Australian manufacturers for all class medical devices and IVDs except Class 4 IVDs.

Feedback to the May 2013 consultation from non-industry stakeholders, particularly from the Consumers’ Health Forum, indicated concern about removing the TGA conformity assessment requirements for Australian manufacturers, as a reduction in the existing level of scrutiny for these medical devices.

However, TGA considers that any change in risk is balanced as this reform is to be implemented in conjunction with the increase in TGA scrutiny for higher risk devices under Proposal A. This approach is consistent with structuring assessment of medical devices based on the inherent risks of the devices, rather than based on the country in which a device’s manufacturer is located.

Assessment of this option against the objectives

This package of reforms addresses all the objectives of the RIS.

It ensures that higher risk medical devices approved do not compromise public health and safety through greater TGA scrutiny of a broader range of medical devices through Proposal A and a more in depth review for AIMD and Class III implantable medical devices to ascertain that there is sufficient evidence supporting the quality, safety and performance of those devices. This is reinforced by the confidence building activities that have commenced.

Proposal C assists to balance this increased scrutiny against retaining the timely availability of medical devices to the Australian public. It achieves this by minimising unnecessary regulatory burden and associated costs and improving the ability for TGA to target emerging risks in a timely manner. Proposal A also ensures that Australia actively addresses the issues identified with European notified bodies in a timely manner, well in advance of regulatory change occurring in Europe by providing its own independent review of the assessment conducted by the EU notified body.

Proposal B also increases public health and safety through providing consumers and health practitioners with better access to information about medical devices to allow them to make more informed health care choices and decide on the level of risk they are willing to accept. Improved transparency is also consistent with what other international regulators are publishing and therefore contributes to the international harmonisation agenda for medical device regulation.

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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

This option proposes to extend the current requirements for a TGA conformity assessment certificate to be issued to cover all AIMD and Class III implantable devices irrespective of where they are manufactured but allows TGA to accept conformity assessment certificates from European notified bodies for all other devices other than Class 4 IVDs. The reasons for excluding Class 4 IVDs at this time are the same as those provided for excluding these devices from Proposal C in Option 2.

Regulation 4.1 currently requires the TGA to issue conformity assessment certificates for specific kinds of high risk medical devices, including those containing medicines or tissues of animal, biological or microbial origin and also for devices manufactured in Australia. This would be amended to also include all AIMD and Class III implantable medical devices, and to remove the requirement for TGA conformity assessment because a device is produced by an Australian manufacturer.

Like Proposal C of Option 2, this option would allow greater TGA scrutiny of a medical device based on the risks of the device rather than the location of the manufacturer. However, it would result in the TGA no longer accepting conformity assessment certificates from European notified bodies for those AIMD and Class III implantable medical devices where this currently occurs and undertaking the conformity assessment itself.

Industry has previously commented that requiring TGA to conduct conformity assessments for all AIMD and Class III implantable devices will significantly increase their costs, delay some products entering the Australian market (with some products being lost to the Australian market altogether) and duplicate the notified body assessment. Previous comments also raised issues about the capacity of the TGA to undertake this workload.

Assessment of this option against the objectives

This option provides greater assurance of the quality, safety and performance of higher risk medical devices as conformity assessment for AIMD and Class III medical devices provides the highest level of assessment possible. However, this option does not address the concern with certain Class IIb implantable or long term surgically invasive medical devices which, in some ways, are of greater concern given that under the medical devices framework in Australian and the EU Class III medical devices should be subject to the highest level of assessment whereas the level of assessment for a Class IIb medical device is not as high. Therefore, this proposal does not increase the number of products subjected to higher scrutiny by the TGA as much as Option 2.

Additionally, there would be no discretion to reduce the level of assessment once confidence building has occurred and is therefore associated with ongoing costs.


Footnotes

  1. In the 2013-14 Budget the Government committed to support enhanced patient contact arrangements for patients with high-risk implantable medical devices. In the event of a recall of a device, hospitals will follow a new national protocol to contact affected patients. Two industry funded clinical quality registries will also be established, to enhance national post market surveillance for high risk implantable devices such as pace makers and breast implants, so that potential faults with devices can be detected more quickly and followed up appropriately.
  2. Amendments to legislative instruments require consultation prior to being presented to Parliament for approval.
  3. Information on the audit structure and documentation requirements is included in the 'Application audit assessments' definition, included at Attachment H: Glossary and acronyms.
  4. <http://www.tga.gov.au/industry/pm-auspar.htm>
  5. <http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/md-im/index-eng.php>
  6. <http://www.tga.gov.au/newsroom/consult-medical-dev...
  7. For example, Class 4 IVDs include assays intended for the clinical diagnosis of infection by HIV 1 and 2, and for screening blood donations for Hepatitis C virus.

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