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

26 June 2013

Book pagination

Attachment F: Summary of consultation on changes to premarket assessment requirements for medical devices

The following summaries submissions made in response to the consultation paper Changes to premarket assessment requirements for medical devices. The paper was released on 14 January 2013, and was open for comment until 15 March 2013.

Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion
Stakeholder Stakeholder comments TGA comments
Support
AMS Laboratories Pty Ltd
  • Disinfectants separated into high level (sterilants and enter body orifice), intermediate level and low level.
  • Sterilants and high level disinfectants= level 2 audit, intermediate and low level disinfectants= level 1 audit. This is not expected to be a burden as few new applications will be received for these products.
In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants.
AusBiotech
  • List of targeted devices in paper is appropriate and should be continually reviewed.
  • Concerned of level 1 audit for MRA applications when could direct resources to post market audits. Audits of MRA certificates to be removed once confidence building occurred.
  • TGA publish formal plan of confidence building activities.
  • Concerns of backlog potential with level 3 audit.
  • Costing needs review to reflect work put into audits.
  • Clear timeframes for audits and penalties to the TGA if not compliant.

Under the proposed arrangements MRA certificates, which are issued to Australian regulatory requirements, will continue to be treated as TGA certificates are (ie no mandatory audit).

Under the amended MRA notified bodies are unable to issue MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue to be valid until their expiration date. After expiration manufacturers may use notified body certification for these devices but it will be subject to audit until such confidence building occurs. See Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013 for more details.

Australian Dental Association Inc
  • Reconsider audit level costs to reflect actual costs involved not per class of device and include upper cost limits for all device classes.
Audit fees relate to the actual costs incurred by TGA. The audit level to apply for a given application is at TGA discretion, however indicative audit levels are indicated in the RIS, and will be reflected in guidance.
Australian Dental Industry Association
  • Audit costs should be determined by actual costs involved and certain classes of device may have different audit cost depending on assessment involved.
  • Look at IRIS reports for devices before determining if certain devices should be subjected to mandatory audit.
  • Dental implants should not be subjected to Level 2 audit.
  • Indirect cost to industry could be 4-7xcurrent application fees.
  • Level 1 audits for MRA certified products is not in line with ERA agreement.
  • Increases regulatory burden and healthcare costs therefore cannot proceed as is.

Audit fees relate to the actual costs incurred by TGA. The audit level to apply for a given application is at TGA discretion, however indicative audit levels are indicated in the RIS, and will be reflected in guidance.

Option 2 allows for identification of Class IIb implantable devices subject to mandatory audit, providing the flexibility to exclude dental implants if this is appropriate. Actual implants to be included for mandatory audit will be subject to further consultation during implementation.

It is not proposed to make devices supported by MRA certificates subject to mandatory audit.

Australian Medical Association
  • Proposal provides balance between access to medical device technology and patient safety.
  • Increased costs to patients possible monitor impact by Private Health Insurance Administration Council.
 
Australian Orthopaedic Association
  • All joint replacements should be Class III
  • New devices for mandatory audit are appropriate
  • No elements of this proposal can be removed without reducing regulatory rigour
  • Support Level 3 audit
  • No comment on Level 3 audit fee
Hip, knee and shoulder joint replacement implants were reclassified as Class III from 1 July 2012. Reclassifying other joint replacement implants in advance of parallel moves in other jurisdictions (particularly Europe) would create significant issues for conformity assessment certification, and may result in numerous products no longer being supplied in Australia.
Bruce Arnold & A/P Wendy Bonython
  • Endorse amendments to Regulation 5.3 including mandatory audits for surgically invasive and long term/implantable devices and adopting foresight to anticipate future device problems.
  • Endorse Level 3 audit and audit fee (outweighed by the priority of consumer safety) and use of raw data from notified bodies.
  • Concerns over quality of EU notified body assessments. Suggested manufacturers provide TGA information where a product not registered overseas or a problem with the device identified by the regulator.
  • Evaluate claims made by manufacturers to ensure safety.
Level 3 audits seek to manage risks for conformity assessments by European notified body for high risk products. Confidence building of notified bodies also being pursued under the MRA.
Cancer Voices Australia
  • Supports increased rigour in premarket assessment of medical devices
 
Consumers Health Forum of Australia
  • Welcome expanded list of devices and Level 3 audit.
  • Concerns over role of EU notified bodies in conformity assessment.
  • Concerns over ANZTPA to ensure it strengthen regulation in Australia.
  • Highlights strengthening of post market surveillance.
Level 3 audits seek to manage risks for conformity assessments by European notified body for high risk products. Confidence building of notified bodies also being pursued under the MRA.
GE Healthcare Australia Pty Ltd
  • All new devices mentioned for mandatory audit are appropriate.
  • Level 3 audit may not be the best way to scrutinise Class III devices as length processing times and costs may discourage suppliers and prevent access to medical devices.
  • Focus resources into post market
It is anticipated that undertaking a Level 3 audit (as proposed in Option 2) will be significantly faster than undertaking a conformity assessment (as proposed in Option 3).
GS1 Australia
  • Use EU System as much as possible to reduce costs.
  • Use National Product Catalogue to ensure consistency of product information.
  • Use bar coding in product packaging
The proposal to introduce Level 3 audits (as an alternative to requiring TGA conformity assessment) aims to reduce duplication (and costs) between Europe and Australia while also providing additional assurance. Confidence building of notified bodies also being pursued under the MRA will also support this.
IVD Australia
  • Clarification that Regulation 5.3(j) and IVD transition period will be unchanged post July 2014.
  • Level 3 audit may result in more companies seeking TGA conformity assessment and therefore increase assessment times.
  • Prefer not to use the words 'raw data'.
  • Level 3 audit possibly necessary for Class 4 IVDs.

The IVD transition period and Regulation 5.3(j) are not proposed to change as part of this proposal but may occur as part of other regulation updates in the future. Such changes would be subject to consultation.

Level 3 audits not proposed to apply to IVDs at this stage – this may be revisited following the IVD transition, and any change would be subject to consultation.

Friends of Science in Medicine
  • Supports proposals for high risk devices, concerned low risk devices will be ignored and adversely affect consumers (especially if not efficacious).
  • Improved post market surveillance required.
  • Highlights the need for devices to be evaluated for efficacy to prevent misleading consumers.
  • Prevent devices cancelled from ARTG to be re-included.
 
Johnson & Johnson Medical Pty Ltd
  • Wish to collaborate on devices selected for mandatory audit as concerns over time costs and increased regulatory burden.
  • Introduce mandatory application audit timeframes and allocate sufficient resources to deal with extra work.
  • What is TGA's value in reviewing notified body assessment reports considering EU notified body problems.
  • Level 3 audit resources should be redeployed after EU notified bodies reformed.
  • Once MRA confidence building completed should abolish Level 3 audits.
  • Improve post market surveillance.
  • Descriptive list of audit levels required for each medical device mandated for audit.
  • Clarification of the 'raw data' required by TGA, Level 2 audit requirements i.e. DE certificates removed for Class IIb devices, grouping of Class IIb applications under one submission ID, continuation of Class IIb as a kind of device (without notifying TGA).
  • Concerns that Class IIb implantable/long term devices evaluated through a Class III audit pathway.
  • Support level 1 audit for disinfectants.
  • Audit fees needs further discussion to ensure fairness and fees according to amount of assessment undertaken.

Further consultation on Class IIb devices to be targeted for mandatory audit will occur during implementation phase. It is anticipated that regular consultation would be required over time to manage the list, to ensure it keeps pace with emerging issues (both adding devices to and removing devices from the list).

Confidence building in EU notified bodies to be conducted in to be conducted in 2013 and 2014 (prior to 1 July 2015 implementation date for Level 3 audit process).

TGA would review the raw clinical data underpinning the conformity assessment report rather than the expert clinical report as occurs for the Level 2 audit, and also the Design Examination report which is currently only reviewed as part of the conformity assessment process. Class IIb devices would generally not be subject to a Level 3 audit, which would be of limited utility given Class IIb devices are not required to hold design or type certification. In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants.

Medical Technology Association of Australia
  • Class III, AIMD and Class IIb implantable should be subjected to mandatory audit as Class IIb long term invasive does not pose a significant risk.
  • Concerns over Level 3 audit increasing premarket assessment when could increase post market assessment.
  • Maintain Level 2 audit (with additional documentation such as design dossier reports requested when required) for Class III and AIMD and increase post market reports to 5 years.
  • Concerned of timeframes for Level 3 audit considering conformity assessment backlog.
  • Clear guidelines on what device is subjected to a specific audit level.
  • Level 2 documentation requirements do not fit Class IIb medical devices.
  • Provided detailed data on costing increases if TGA incorporates a Level 3 audit.

Introduction of instrument to identify Class IIb devices for mandatory audit allows consideration of risks of different devices, and flexibility to target emerging risks over time.

Clear guidance on expected audit levels will be provided, although TGA will retain the discretion to vary this in individual cases, as devices are audited not only based on 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.

National E-Health Transition Authority
  • These reforms provide opportunities to incorporate other healthcare reforms and change mandatory requirements to ARTG listings.
 
NSW Department of Health
  • Supportive, especially of implantable devices.
  • Concerns that reduction in assessment for disinfectant devices will compromise patient safety.
In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants.
Professor Guy Ludbrook
  • List of new devices subjected to audit seems appropriate.
  • Level 3 audit provides greater scrutiny in information provided in applications and in raw data.
  • Consider types of devices and risk before subjecting to Level 3 audit.
  • Clarification of whether sub-classifications align with different risk levels and audit type?
The introduction of the instrument to identify additional Class IIb devices for mandatory audit aims to allow for assessment of varying risk levels and audit types within the Class IIb (medium – high risk) devices.
Robert Lugton
  • Every Class III implantable medical device should be subjected to Level 3 audit confirming the manufacturer has a minimum of two years of pre market trials. $15,000 for level 3 audit is not appropriate (implied more money necessary).
The proposed changes under Option 2 seeks to balance the need for additional premarket scrutiny of Class III devices against the expense of such changes.
Stellar Consulting
  • Clarification required as to the purpose of the level 1 audit for MRA certificates as removes incentive for MRA certificates.
  • Clarification of the statement "conformity assessment certificates from European notified bodies would continue to be accepted for devices not on this list". Does this mean that certificates from EU notified bodies would not be accepted for devices on the list, requiring instead a TGA conformity assessment certificate?
  • Contact lens care products, instrument grade disinfectants and sterilants should be subjected to level 2 audit to allow for assessment of safety and performance data and prevent disease transmission. Changing classification of these devices will not assess efficacy (which is the reason they are Class IIb in Australia compared to Class IIa in EU).
  • Review Barrier contraceptives (both male and female condoms) in Regulation 5.3 or review the wording of Regulation 5.3 and consider the compliance of the products with the standards. Currently condoms are excluded from the MRA but included in the ARTG with EC certification and no audit assessment (inconsistent with EU).

Under the proposed arrangements MRA certificates, which are issued to Australian regulatory requirements, will continue to be treated as TGA certificates are (ie no mandatory audit).

Under the amended MRA notified bodies are unable to issue MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue to be valid until their expiration date. After expiration manufacturers may use notified body certification for these devices but it will be subject to audit until such confidence building occurs. See Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013 for more details.

In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants.

Those devices currently identified under Regulation 5.3 for mandatory audit will be reviewed in consultation with stakeholders as part of implementation for Option 2.

Stryker South Pacific
  • No mandatory audit for Class IIb surgically invasive for long term use devices.
  • Class 3 audits may be unnecessary as Class 2 gives consistent oversight.
  • Concerns over cost and delay in product approval associated with Class 3 audits. Possibly group products (similar to Class III mandatory audit)
Introduction of instrument to identify Class IIb devices for mandatory audit allows consideration of risks of different devices, and flexibility to target emerging risks over time. Option to group audits for Class III products will be available under Option 2.
William A Cook Australia Pty Ltd
  • Ambiguity of level of scrutiny of level 3 audits
  • Pre market process should be identical between EU and Australian manufacturers.
 
Name not to be published at submitters request
  • New devices listed for mandatory audit appropriate.
  • Reclassify Class IIb implantable/long term use devices as "medium high" risk devices.
 
Not support
Global Orthopaedic Technology
  • Current way to regulate medical devices provides sufficient scrutiny.
  • Proposal penalises sponsors choosing Notified Bodies over TGA assessment.
  • Increases costs and lack of product choice for surgeons and patients.
 
Integra Neurosciences Pty Ltd
  • Premarket assessment will not ameliorate 100per cent of the risk- efforts should therefore be focused towards post market (through annual reports).
  • Suggested to wait for EU changes to occur.
  • Not specifying additional documentation required for a Level 3 audit may cause backlog of applications.
Acknowledge that premarket assessment of medical devices must be complimented by post market surveillance measures. Additional scrutiny is targeted to implantable devices due to the particular difficulties these pose when postmarket issues arise.
Medical Technology Association of New Zealand
  • Increased costs for applications, put resources into post market, NCAR, MDSAP, & UDI.
  • Question whether the TGA has technical expertise to assess high risk devices.
  • Increased regulatory burden without increased rigour.
  • Concerns that Australian is adopting reforms ahead of ANZTPA and New Zealand will have to accept these reforms.
 
N Stenning & Co Pty Ltd
  • Improved post market surveillance more effective than premarket.
  • Concerns on EU MRA amendments- increase application costs and delay new product introductions to market. Therefore, reinstate EU MRA certificate acceptance.
  • Clarification of the statement "greater assurance in the quality, safety and performance of medical devices" required.
No notified bodies have confidence building agreements in place with the TGA. Under the amended MRA notified bodies are unable to issue MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue to be valid until their expiration date. After expiration manufacturers may use notified body certification for these devices but it will be subject to audit until such confidence building occurs. See Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013 for more details.
ResMed Ltd
  • Current level of scrutiny is appropriate
 
Name not to be published at submitters request
  • Increased regulatory burden and cost to patients.
  • Dental implants should be mandated for audit only if safety or performance issues identified.
 
Name not to be published at submitters request
  • Increased regulatory burden and cost to patients.
  • Dental implants should be mandated for audit only if safety or performance issues identified.
Option 2 allows for identification of Class IIb implantable devices subject to mandatory audit, providing the flexibility to exclude dental implants if this is appropriate. Actual implants to be included for mandatory audit will be subject to further consultation during implementation.
Name not to be published at submitters request
  • Level 1 audit not appropriate for devices outlined in consultation paper and no higher audit level required either.
  • Don't support Level 2 audit for Class IIb implantable or long term surgically invasive medical devices as they have been used safely with no post market events.
  • Product groups with reported safety problems should have a mandatory audit under Regulation 5.3.
  • Don't support Level 3 audit as increases cost to production.
  • Increased premarket scrutiny won't improve public safety as adverse events occur years after implantation.
  • Don't increase regulatory burden til EU reforms are in place.

The reasons for selecting particular audit levels do not relate only 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.

Acknowledge that premarket assessment of medical devices must be complimented by post market surveillance measures. Additional scrutiny is targeted to implantable devices due to the particular difficulties these pose when postmarket issues arise.

Proposed implementation of Option 2 would be from 1 July 2015, which would mean EU reforms should be more advanced, and confidence building in notified bodies progressed.

Name not to be published at submitters request
  • No benefits identified to adding Level 1 audit to MRA certificates.
  • No benefit identified in Level 3 application audits.
  • Increased costs and time associated with application assessments.
  • Duplication of EU assessments.
  • Difficult to obtain design exam certificates for Class IIb devices.
  • Post market mechanisms should be utilised instead to improve patient safety such as review of mandatory annual reports for Class IIb implantable and Class III and AIMD devices.
  • Clarify:
    1. Why is a level 1 audit required for conformity assessment certificates issued by Notified Bodies which the TGA has confidence in?
    2. Why include long term surgically invasive, what evidence is of a need to include this group?
    3. How does the new level 3 application audit for AIMD and Class III, increase the rigour of assessment?

Under the proposed arrangements MRA certificates, which are issued to Australian regulatory requirements, will continue to be treated as TGA certificates are (ie no mandatory audit).

Under the amended MRA notified bodies are unable to issue MRA certificates for Class III devices until confidence building is undertaken. Existing MRA certificates continue to be valid until their expiration date. After expiration manufacturers may use notified body certification for these devices but it will be subject to audit until such confidence building occurs. See Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013 for more details.

Acknowledge that premarket assessment of medical devices must be complimented by post market surveillance measures. Additional scrutiny is targeted to implantable devices due to the particular difficulties these pose when postmarket issues arise.

The reasons for selecting particular audit levels do not relate only 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.

Introduction of instrument to identify Class IIb devices for mandatory audit allows consideration of risks of different devices (including surgically invasive), and flexibility to target emerging risks over time.

Name not to be published at submitters request
  • Disinfectants and sterilants should be subjected to Level 2 audit to prevent performance compromise.
  • Instigate biannual or triannual audits.
In response to consultation feedback the proposal to reduce audits of disinfectants from a Level 2 to a Level 1 audit has been modified. Level 2 audits will be maintained for liquid disinfectants, with Level 1 audits for hardware such as autoclaves. This allows for a microbiological assessment of liquid disinfectants.
No comment
Accord Australasia Ltd    
Name not to be published at submitters request    

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Proposal B: Publication of TGA regulatory decisions
Stakeholder Stakeholder comments TGA comments
Support
Accord Australasia Ltd
  • Publication of successful applications of high risk devices only.
  • Don't publish unsuccessful decisions and 'interesting' devices difficult to define.

The format for publishing medical device decisions to assume a format similar to the AusPAR, with the final format to 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.

Publication of negative decisions is an important element to ensure transparency of the regulatory process.

Phased implementation proposed.

AusBiotech
  • Information to be clear, concerns over publishing withdrawn and rejected decisions.
Australian Dental Industry Association
  • Only publish applications for inclusion including the degree of assessment undertaken.
  • Publication of conformity assessment decisions may provide competitors with advantages.
  • Do not publish rejected decisions.
  • Do not publish confidential information.
  • Definition of "more interesting" devices difficult to define.
Australian Medical Association
  • Provides balance between timely access to technology and patient safety.
Australian Orthopaedic Association
  • Increased transparency is beneficial
  • All information for orthopaedic prosthesis except commercial sensitive information should be disclosed
Bruce Arnold & A/P Wendy Bonython
  • Publication of successful and unsuccessful decisions including level of scrutiny undertaken.
  • Information should be published timely and ongoing (i.e. not every 6 months).
  • Intellectual property responsibilities lie with manufacturers and not TGA.
Cancer Voices Australia
  • All models or variation of a device included in the ARTG are to be clearly identified.
  • ARTG number should be printed on the information that accompanies the device.
  • Product information should be published on the TGA website to enable consumers to make informed decisions about safety and efficacy.
Consumers Health Forum of Australia
  • Supports publication of both conformity assessment and device application decisions (both successful and unsuccessful).
  • Supports publicising decisions on Class III and implantable medical devices- but ideally all devices publicised.
  • Medical Device regulatory decisions to be published.
GE Healthcare Australia Pty Ltd
  • Publication does not delay inclusion.
  • In confidence information is not published and information discussed with manufacturers at the start.
  • Information is regularly updated.
  • Initially only successful applications for inclusion in ARTG.
IVD Australia
  • Concerns of publicising unsuccessful applications and all conformity assessment decisions.
  • Limited to Class 3, Class 4 IVDs and Class III and AIMD medical devices.
  • Concerns that publication will hold up IVD inclusion.
  • Publication of "interesting" devices would be difficult to set criteria and may indicate that "interesting devices" only are subjected to review.
  • Want reports on number of conformity assessment applications and successful, unsuccessful and withdrawn ARTG applications, reasons for rejection and assessment time per class to aid industry understanding.
  • Do not publish auto included device decisions.
Johnson & Johnson Medical Pty Ltd
  • Do not include automatically approved inclusions.
  • Publish successful decisions on Class IIb implantable, Class III and AIMD for applications to include in the ARTG.
  • Do not publish unsuccessful decisions.
  • Publish the degree to which a medical device has been assessed.
Medical Technology Association of Australia
  • Should exclude publication of Class I auto inclusion decisions.
  • Publication should be quick and limited to Class IIb implantable, Class III and AIMD devices.
  • Sponsor should be able to review material prior to publication.
  • Publication of unsuccessful applications should be publicised after appeal rights exhausted but concerns were raised over competitor advantages, reputational damage to companies if published and misinterpretation of rejected and withdrawn applications. These concerns were not however realised in the medicine context after introduction of AusPAR.
  • Also publicise precedents or standards after they have been set by particular applications.
  • All comments related to applications for inclusion only.
Medical Technology Association of New Zealand
  • Further consult about what kinds of devices to be published.
  • Concerns over confidentiality of published information.
NSW Department of Health
  • Important to consider how information will be accessed by the public
  • Transparency may clearly identify devices not included in the ARTG and used via SAS
Professor Guy Ludbrook
  • Publishing successful and unsuccessful decisions of high risk devices such as those subjected to mandatory audit or Class IIb where clinical evidence has been assessed.
  • Confidentiality concerns raised.
  • Ensure consultation with advisory groups.
ResMed Ltd
  • Information needs to be accurate, not disclose confidential information and not burden manufacturers.
  • Suggested not to publish rejected decisions and start with publication of high risk devices.
Stryker South Pacific
  • Follow AusPAR process with review and appeal rights.
William A Cook Australia Pty Ltd
  • Consult company before releasing information. Follow similar guidelines to the FDA.
Global Orthopaedic Technology
  • Information not currently released on public ARTG summary as it is commercial in confidence.
  • Rejections could be used by competitors as a marketing tool.
  • Information may be accidently released when not meant to.
  • All relevant information already included in public ARTG summary.
Integra Neurosciences Pty Ltd
  • No health and safety benefit of publicising unsuccessful decisions.
Name not to be published at submitters request
  • Successful Class III, AIMD and Class IIb implantable application decisions publicised only.
  • Do not include automatic entries, "interesting products", unsuccessful decisions, and conformity assessment decisions.
Name not to be published at submitters request
  • Approval decisions for application for inclusion only. No benefit to public if rejections are published.
  • Concerns that publication will delay ARTG inclusion.
  • Clarification required if this is similar to AusPAR.
Name not to be published at submitters request
  • Class III, AIMD, and Class IIb implantable to be publicised, if rejected- only information on safety and efficacy to be published for rejected applications.
  • If publish low risk decisions- only successful applications.
Name not to be published at submitters request
  • Class III, AIMD, and Class IIb implantable to be publicised, if rejected- only information on safety and efficacy to be published for rejected applications.
  • If publish low risk decisions- only successful applications.
Name not to be published at submitters request
  • Publication of successful applications for inclusion decisions for Class III, AIMD and Class IIb implantable only.
  • Do not publish conformity assessment decisions or unsuccessful decisions.
  • Publication of variant types and functional description reinstated on ARTG certificates.
Name not to be published at submitters request
  • Trial Class III, AIMD and Class IIb implantable first.
  • Do not publicise withdrawals due to numerous reasons for withdrawing applications.
Not support
     
No comment
     

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Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical device
Stakeholder Stakeholder comments TGA comments
Support
Accord Australasia Ltd
  • Prefer abolish TGA conformity assessment for all devices
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
AusBiotech
  • Should be for all Australian manufacturers
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Australian Dental Industry Association
  • This proposal should be progressed independently of Proposal A.
  • Also include Class IIb surgically invasive for implantable/long term use.
The link between Proposal A and Proposal C is necessary. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
Australian Medical Association
  • Provides balance between timely access to technology and patient safety
 
Australian Orthopaedic Association
  • Risks of abolishing conformity assessment for low risk devices may pose a risk. Cost/benefit and impact analysis needs to be conducted. Health funding is a finite resource.
  • Believes that the proposal is reasonable

Low risk medical devices are devices where use of the device constitutes low risk to the public – Class I medical devices are defined as 'low risk', and conformity assessment for these devices is already certified by the manufacturer.

Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.

Cancer Voices Australia
  • Clarification of the statement 'low risk'
  • Supports 3rd party assessment of low risk devices with certified 3rd parties.
Low risk medical devices are devices where use of the device constitutes low risk to the public – Class I medical devices are defined as 'low risk'.
Consumers Health Forum of Australia
  • Concerns raised of quality of EU notified bodies and assessment processes.
  • Only implement if proposal A is implemented.
  • If Proposal C is implemented, even more important to publish regulatory decisions for all devices.
  • Review risk classifications if proposal implemented- if not can place consumers at risk.
Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
GE Healthcare Australia Pty Ltd
  • Enables resources to be focused into high risk devices.
 
IVD Australia
  • Abolish TGA conformity assessment for Class 1-3 IVD's and possibly even Class 4 IVD's.
  • Concerns abolishing TGA requirement will result in more Level 3 audits.

Proposal to apply to IVD manufacturers – although not manufacturers of Class 4 IVDs at this time (this may be revisited at the end of the IVD transition period).

Manufacturers relying on EU certification are subject to greater when applying for inclusion on the ARTG than those holding TGA or MRA conformity assessment certification, and this may include audit requirements. All manufacturers continue to have the option to seek TGA conformity assessment, and this is a business decision they need to make in the context of their operational requirements.

Johnson & Johnson Medical
  • Support and wish for expansion to cover all medical devices.
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Medical Technology Association of Australia
  • Support abolition of TGA conformity assessment for low risk devices but confidence building should be completed before ANZTPA so quality of high risk devices also assured.
Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
Medical Technology Association of New Zealand
  • Abolish TGA conformity assessment for all classes of medical devices to prevent disadvantage to Australian companies.
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Professor Guy Ludbrook
  • Success of the proposal depends on quality of overseas conformity assessment
For this reason Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
ResMed Ltd
  • Clarification required whether this will prevent manufactures obtaining quality system certification from the TGA- thus impacting supply in Southeast Asia and South American countries.
  • Supportive of these changes for all classes of device.
All types of conformity assessment certificates will still be offered by the TGA.
Stryker South Pacific
  • Supports- Make use of Notified Bodies ASAP
 
William A Cook Australia Pty Ltd
  • Should extend to Class III, AIMD and Class IIb implantable devices as well and then undergo a Level 3 application audit.

Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers.

Manufacturers relying on EU certification are subject to greater when applying for inclusion on the ARTG than those holding TGA or MRA conformity assessment certification, and this may include audit requirements.

Name not to be published at submitters request
  • Supports proposal as is
 
Name not to be published at submitters request
  • Proceed even if Proposal A not implemented. No TGA conformity assessment for devices other than Class III, AIMD and Class 4 IVDs, implantable medical devices and/or surgically invasive devices intended for long term use.
Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
Name not to be published at submitters request
  • Aim towards abolishing conformity assessment for high risk devices as well.
  • Support proposal as is.
  • Accept 3rd party conformity assessment certificates from TGA designated agencies for all Class III/AIMD medical devices.
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Name not to be published at submitters request
  • Aim towards abolishing conformity assessment for high risk devices as well.
  • Acknowledge IMDRF work and develop single audit to recognise 3rd party assessments.
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Name not to be published at submitters request
  • All Australian manufactured devices to use EU reports.
Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers
Name not to be published at submitters request
  • The proposal should encompass any device that has undergone EU conformity assessment certification.
  • TGA needs to end confidence building and designate notified bodies that meet audit criteria and align with international regulators.

Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers

Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.

Not support
Global Orthopaedic Technology
  • Increased costs and prevention of Australian consumer’s access to products
Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers.
NSW Department of Health
  • Implied not support- what other mechanisms in place to ensure device safety standards.
  • Suggested simplification of processes rather than abolition
 
Bruce Arnold & Dr Wendy Bonython
  • Concerns over EU notified bodies.
  • Level of scrutiny seems to be discretional.
 
No comment
     

Other issues: IVD Australia recommends the term 'raw data' not to be used as it implies individual data points.

Comments outside of the scope of proposal 2- Cancer Voices Australia: (1) Support the idea of all models and variations of a device be registered to ensure safety of use and to remove confusion as to what exactly is registered and what is not. (Proposal 3 – Product name); (2) Strongly support more product information being required to be published on the TGA website. (Proposal 4)

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