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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

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Impact analysis

The proposals provided above all impact on consumers, laboratories, industry and bodies or individuals associated with the IVD sector.

Impact of each proposal

Proposal 2A: modified CA procedure for the regulation of Class 4 in-house IVDs, predicated on commercial IVDs.

The majority of stakeholders acknowledged and supported the need for change to the CA procedures for the regulation of Class 4 in-house IVDs, particularly those predicated on commercial IVDs. Stakeholders considered that the proposal would reduce the regulatory burden on laboratories and avoid unnecessary duplication by limiting the evaluation assessment to the validation of any differences between the Class 4 in-house IVD and the predicate product.

Although industry's preference was that no changes be made to the agreed and legislated IVD framework there was recognition that this was not practical given the potential impact on donor screening services. They recognised the difficulties that laboratories would have supplying (as part of their application to the TGA) complete manufacturing information for an in-house IVD that was based on a commercial IVD.

The majority of those within industry (that were aware of the need for change) supported a proposal for a modified CA procedure for Class 4 in-house IVDs, predicated on commercial IVDs. There was agreement within the sector that undertaking a full CA for what has been determined to be a minor change to a registered product is excessive. The proposal was regarded as a reasonable compromise between patient safety and the practical challenges presented by some relatively low volume tests such as those used for testing cadaveric donor samples. However, there was disappointment that the proposed amendments to the CA procedures did not provide any similar reduction in the regulatory burden for those commercially supplying IVDs in Australia.

Some industry responses did not support the use of Class 3 IVDs for routine supplemental donor screening (e.g. donor screening for malaria) unless there was no commercial Class 4 IVD alternative available. Industry respondents considered that the introduction of this measure would be a strong disincentive for commercial manufacturers to develop and commit the resources required to validate IVDs for this purpose. One submission to the consultation paper cautioned that amending the requirements to allow Class 3 IVDs to be used as Class 4 IVDs may inadvertently create a loophole that exempts high risk assays from the requisite regulatory review, as the TGA registration process for a commercial Class 3 IVD does not necessarily require pre-market assessment of the product. This is a valid point that would need to be taken into consideration when determining the level of evaluation required by the TGA for these particular Class 4 in-house IVDs.

If this proposal was to be accepted, industry respondents would like to see a prescriptive list of acceptable modifications and further information about the fees and charges that would be applied to a modified Class 4 in-house IVD. There was some concern regarding the proposed classification of modifications as being either minor or fundamental.

Generally there was a sense that the TGA would need to provide comprehensive guidance that defined what constitutes an appropriate level of validation, and the types of modifications that would be considered minor. It was recognised that laboratories would need to seek a final ruling from the TGA as to whether the modification(s) 'represent a fundamental change to design' and hence which type of CA would be required. Industry considered that the same level of assessment and fees should apply to both a laboratory modified IVD and changes made by the commercial manufacturer to a registered commercial IVD.

If a modified CA procedure were adopted industry respondents considered that laboratories maintaining GMP licences would have an adequate level of scrutiny in place to manufacture Class 4 in-house IVDs. However concerns were expressed that NATA accreditation (ISO 15189) alone was insufficient and should not be considered as an alternative. Additionally, there was a concern that there may be a divergence in compliance depending on whether a laboratory was assessed to NATA accreditation or to GMP licensing requirements.

However, limiting the requirements to the need for a GMP licence would restrict the number of laboratories that could access the modified CA procedure. Laboratories that provide donor screening services for organ transplantation and cord blood banking are not required to hold a GMP licence and thus would not be eligible to apply for a modified CA procedure for their Class 4 in-house IVDs. These laboratories do however hold NATA accreditation and have successfully provided these services in Australia prior to the introduction of the new framework. NATA accreditation to ISO 15189 is considered by the TGA to be an appropriate and acceptable standard for demonstration of a QMS for a medical testing laboratory that develops Class 4 in-house IVDs that are based on commercial IVDs.

Rather than reducing regulation this proposal allows laboratories to demonstrate compliance with an alternative standard (ISO 15189) for a QMS that is more practical and relevant to medical laboratories. Compliance with this standard is already accepted by the TGA as evidence of an appropriate QMS for Class 1-3 in-house IVDs. The quality, safety and performance of the Class 4 in-house IVD would be continue to be assured as the changes made to the commercial IVD product would still require evaluation by the TGA.

Not all Class 4 in-house IVDs would benefit from this proposal as de novo Class 4 in-house IVDs and a number of Class 4 in-house IVDs (where the modification to the commercial IVD was considered to be a fundamental change to the design of the IVD) would still be required to apply for a full TGA CA. Laboratories expressed concern that although the proposal was an improvement on the current arrangements, they still considered that the supply of some critical pathology tests would be compromised or cease in Australia after the transition period as it still imposes an unachievable level of regulation for some Class 4 in-house IVDs, particularly for de novo Class 4 in-house IVDs. Those affected have indicated that it would be uneconomical for them to continue to provide these services if they were required undergo a full CA procedure and pay the associated fees.

These would be predominantly low volume tests for uncommon diseases/disorders used for a specific purpose and include anti-sera used to detect rare or weak antigens to assess compatibility for blood transfusion, HIV proviral DNA testing in neonates, and testing for exotic and emerging diseases. If this proposal was to be adopted there is a high risk that these tests would no longer be available in Australia as they would not be able to meet the proposed CA process.

Under this proposal, the limited CA requirements for Class 4 in-house IVDs based on commercial IVDs where the modification does not represent a fundamental change to the design are expected to be associated with a commensurate reduction in the applicable fees and charges. There was some reluctance by stakeholders to provide detailed information on how the proposals would affect their businesses financially and they commented that they would prefer to see a proposed fee structure prior to providing further comment. However, many anticipated that there would be a reduction in the fees (for laboratories) if there were an amendment to the new regulatory framework to reduce the level of assessment required for in-house IVDs and this was implied in the consultation paper. It was recognised that under any of the proposals there would still be substantial fees for laboratories with a high number of Class 4 in-house tests. There is no reduction in regulatory burden or costs for the commercial industry under this proposal.

Proposal 2B: modified CA procedure for the regulation of all Class 4 in-house IVDs.

Proposal 2B is intended to reduce the regulatory burden on laboratories and increase the capacity of laboratories to comply with the new regulatory requirements while still maintaining the TGA regulatory oversight for all Class 4 in-house IVDs. All laboratories producing Class 4 in-house IVDs (de novo and modified commercial) would benefit from this proposal through a reduction in cost and an increased ability to comply with the regulatory requirements.

The majority of those in support of this proposal were laboratories, as it was considered to be a practical approach that addresses the compliance concerns and reduces the regulatory burden on laboratories that manufacture Class 4 in-house IVDs while providing sufficient risk management and scrutiny of these tests.

Amending the framework to provide a modified CA procedure for the regulation of all Class 4 in-house IVDs is likely to allow IVDs, for which there is no commercial alternatives, (including HIV proviral DNA testing for neonates, tests for exotic and emerging pathogens, and nucleic acid testing for organ and tissue donors) to continue to be available for use.

Those who supported the proposal agreed that in-house IVDs should not be required to be included in the ARTG as they considered that the ARTG should only include products that can be lawfully supplied on the Australian market (in-house IVDs cannot be legally supplied outside a laboratory or laboratory network). However, others expressed concern that there would be a reduction in the level of transparency if Class 4 in-house IVDs were not required to be included in ARTG.

Industry was prepared to support a modified CA procedure for Class 4 in-house IVDs that were predicated on a commercial IVD that had already been included in the register and where the modification did not significantly impact on the design of the commercial IVD. However, they considered that a modified CA procedure for all Class 4 in-house IVDs may not deliver an appropriate level of regulatory oversight required for high risk IVDs, particularly those developed de novo.

Industry respondents considered Proposal 2B inappropriate as it would create an 'uneven playing field' where non-commercial IVDs were not subjected to the same level of scrutiny (or fees) as commercial IVDs, and would lead to a two tiered regulatory system - one tier for laboratory manufactured IVDs and a second for commercially manufactured IVDs. This system was considered a disincentive for manufacturers to develop commercial Class 4 IVDs for the Australian market due to the higher regulatory burden and fees payable than laboratory developed IVDs.

As with Proposal 2A the limited CA requirement would be associated with a commensurate reduction in the applicable fees and charges for laboratories. There is no reduction in the regulatory burden or costs for the commercial industry under this proposal.

Proposal 2C: modified CA procedure for the regulation of all Class 4 IVDs and Australian manufactured Class 2 and 3 IVDs.

Proposals 2A and 2B put forward options for reducing the regulatory burden for laboratories developing Class 4 in-house IVDs however neither proposal provides a mechanism for easing the regulatory burden on commercial manufacturers of IVDs. The majority of IVD stakeholders supported some form of modification to the current CA procedure for Class 4 in-house IVDs however were disappointed that the proposed amendments in the consultation paper did not take into consideration the regulatory burden on commercial manufacturers.

Proposal 2C has evolved as a result of the consultation process and provides a modified CA procedure for all Class 4 IVDs (both commercial and in-house) and Australian manufactured Class 2 and 3 IVDs. It has taken stakeholder views into consideration and significantly decreases the regulatory burden and increases the ability of both commercial manufacturers and laboratories to comply with the regulatory requirements and ensure that critical Class 4 in-house IVDs continue to remain available in Australia, while not compromising public health and safety.

Commercial and laboratory manufacturers of Class 4 IVDs applying for this modified procedure would be required to provide the TGA with acceptable CA evidence of a QMS. As with proposals 2A and 2B laboratories would be required to maintain a GMP licence or NATA accreditation as a medical testing laboratory (and demonstrate compliance with the NPAAC standard). Commercial manufacturers of Class 4 IVDs would be required to provide acceptable evidence of QMS CA certification from a European notified body (i.e., third party QMS CA).

Where these conditions were met, the modified CA procedure for Class 4 IVDs would consist primarily of an evaluation by the TGA of the data validating the performance of the Class 4 IVD and evaluation of compliance with the EPs. On application to the TGA for this modified CA the level of evaluation required would be determined by the TGA and an evaluation fee commensurate with the amount of work to be performed would be charged. Proposal 2C provides an appropriate and practical level of regulation that still maintains a high level of patient safety.

Under this proposal acceptable third party CA evidence of a QMS could also be used by Australian commercial manufacturers to support their applications for inclusion of Class 2 and 3 IVDs in the ARTG. Certain products, such as self-tests and tests that can be used at the point of care, would still require product review by the TGA prior to entry in the ARTG. This would be consistent with what is currently accepted for overseas manufacturers of Class 2 and 3 IVDs. Australian IVD manufacturers supplying their products in Australia and Europe would no longer be disadvantaged compared to their overseas counterparts. Commercial manufacturers would still retain the option to apply for TGA CA Certificates if desired.

The acceptance of third party QMS evidence for commercial manufacturers and GMP or NATA accreditation for laboratory manufacturers of IVDs is not considered to be a significant reduction in regulatory oversight but rather minimising duplication of work and providing greater flexibility for manufacturers to demonstrate that they have an acceptable QMS for the manufacture of IVDs (whether they be commercial or in-house). A more coordinated approach and a reduction in duplication is something that both industry and laboratories have been seeking from the TGA for some time. Under this proposal any (potential) increased risk to public health is minimised as all high risk (commercial and in-house Class 4) IVDs would still require assessment of quality, safety and performance by the TGA prior to entry in the ARTG and being made available on the Australian market.

However there continues to be concern from some laboratories that a number of low volume in-house IVDs for specific disease categories (i.e., an assay used for testing Human T-cell Lymphotropic Virus (HTLV-1) disease in Australian Aboriginal populations) would still be unable to comply with the requirements and these tests would therefore no longer be available in Australia after the transition period.

Additionally without amendments there is a risk that essential low volume specialised IVDs (required in the national interest and in the event of a public health emergency to detect exotic and emerging diseases, including infectious agents deemed to be security sensitive biological agents) would no longer be available. This was seen as potentially weakening Australia's national security by diminishing our capacity to rapidly respond and detect biological and infectious agents that may constitute a serious threat to public health. A number of stakeholders considered that this could be addressed by providing exemption provisions for these tests to ensure that they would be available as the need arises.

In response to this concern, amendments to the existing exemption provisions in the Act and Regulations may be required (as referred to in Proposal 2C) to address some of the outstanding stakeholder concerns regarding continued access to specialised IVDs, particularly Class 4 in-house IVDs, in certain circumstances. Exemption provisions are already provided in the Act for medical devices subject to conditions in the Regulations however they do not adequately address exemptions for IVD medical devices. Amendments to the Regulations may be required to allow the supply of IVDs for special or experimental purposes in certain circumstances. Suppliers of commercial IVDs and manufacturers of in-house IVDs would potentially be eligible for an exemption if appropriate.

The CA requirements put forward in this proposal are expected to be associated with a commensurate reduction in the applicable fees and charges and reduce the regulatory burden for both commercial and laboratory manufacturers of IVDs while still maintaining a high level of quality and safety.

Two additional concerns described below, were raised by stakeholders during the consultation process in relation to the regulatory requirements for Class 1-3 in-house IVDs and the risk classification for Class 3 IVDs. It is considered that both of these concerns are best addressed in conjunction with Proposal 2C.

A number of laboratories using Class 1-3 in-house IVDs have indicated that they are NATA accredited to an alternative quality management standard (ISO 17025 as opposed to ISO 15189) as they are not considered to be 'medical testing' laboratories, while others do not operate under an Approved Pathology Authority (APA) as they do not access Medicare reimbursement. Laboratories have also indicated that the notification process for Class 1-3 in-house IVDs is both onerous and inefficient. Minor amendments to the Regulations are proposed so that the requirements are both less prescriptive and offer laboratories greater flexibility in the way in which they comply with the Regulations for lower risk Class 1-3 in-house IVDs.

It is proposed that NATA accreditation to ISO 17025 would also be accepted as evidence of an appropriate QMS for laboratories that manufacturer Class 1-3 in-house IVDs. The ISO 17025 standard actually forms the basis of ISO 15189 and, from a quality management perspective, is considered by the TGA to be equivalent. It is also proposed that the requirement for a laboratory to provide the TGA with a list of their Class 1-3 in-house IVDs could be replaced with a declaration of conformity that identifies the 'kinds' of in-house IVDs and that they comply with the EPs. Laboratories would still be required to notify and provide the TGA with information on their NATA accreditation status.

Also identified, as a concern, is the IVD risk classification rule in the Regulations that refers directly to the National Notifiable Disease List (NNDL) (a list maintained by the Department of Health). Under this rule, an IVD intended to detect a pathogen listed on the NNDL is automatically deemed to be a Class 3 IVD. This list is not controlled by the TGA and any addition to the list may result in the up-regulation of a Class 2 IVD to a Class 3 IVD without any industry consultation. If the sponsor of the IVD is unable to comply with the regulatory requirements for a Class 3 IVD it may result in the removal of the product from the Australian market. Amendment to the TGA classification rule is proposed to ensure that the regulatory responsibility for determining 'What is a Class 3 IVD?' resides with the TGA and that any up-classification of an IVD occurs only after appropriate consultation.

Proposal 2D: retain the current regulatory framework for all Class 4 IVDs and Australian manufacturers of Class 2 and 3 IVDs (status quo).

There was little support for the proposal of retaining the current CA requirements for Class 4 IVDs, particularly for Class 4 in-house IVDs, and Australian manufactured Class 2 and 3 IVDs, as the risks associated with maintaining the status quo are considered to be too high.

The current requirement for manufacturers of Class 4 IVDs (commercial and laboratory in-house) and Australian manufacturers of Class 2 and 3 IVDs to undergo TGA CA is considered by the majority of stakeholders to be an unreasonable constraint and disadvantages Australian manufacturers compared to their overseas counterparts. Industry has commented that the requirement to undergo TGA CA significantly increases costs, will result in the removal of IVDs from the Australian market, may delay timely access to new technology and unnecessarily duplicates assessments undertaken by notified bodies. CA is considered by stakeholders to be an intensive and costly process. The unnecessary duplication of work drives up the cost of IVDs and creates a disincentive to supply products in Australia's relatively small market.

Laboratories using modified commercial IVDs indicated that they would generally be unable to comply with the regulatory requirements for Class 4 in-house IVDs as they have neither control over the design and manufacturing processes for the commercial IVDs nor access to the commercial manufacturer's technical documentation. A laboratory can only provide the technical evaluation performed to validate the modification made to the commercial IVD. In addition, the costs associated with compliance with the new framework would make it non-viable for many laboratories to continue to provide testing services using Class 4 in-house IVDs, particularly as many are not-for-profit organisations.

Currently in Australia there is a lack of suitable commercial serology IVDs available that can be used by laboratories to screen cadaveric tissue donors for infectious diseases (i.e., HIV, HCV, HBV, HTLV and Syphilis) and laboratories have had to develop their own Class 4 in-house IVDs to address this issue. Although one commercial supplier has indicated that they will validate their commercial serology IVDs for use with cadaveric samples there was concern from stakeholders that even if all laboratories were able to use these IVDs this would lead to a reliance on one commercial platform with no back-up options available in Australia if there were problems. There also remains the outstanding issue of supplemental donor screening for additional infectious disease (e.g., Malaria, West Nile Virus). For many of these tests, commercial IVDs are unavailable for donor screening and laboratories would still be required to develop Class 4 in-house IVDs for this purpose.

The Consumer Health Forum of Australia (CHF) was not supportive of any changes to the CA procedure for the regulation of IVDs. The CHF commented that laboratories must be able to demonstrate that an IVD and its manufacture, or modification, conform to the current legislation because of the level of risk associated with these tests. Although the proposals put forward in the consultation paper retained the requirement for manufacturers to provide appropriate evidence of a QMS to the TGA and the evaluation of all Class 4 IVDs by the TGA for quality, safety and performance, the retention of the current system was regarded by the CHF to be in the best interests of end-users and consumers.

However, the view of the majority of stakeholders was that if the current framework for all Class 4 in-house IVDs were retained there may not be any appropriately validated assays for some high risk conditions and this would result in certain services, including transplantation and transfusion services, being compromised or withdrawn. In many cases (at the end of the transition period) laboratories will no longer maintain and develop specialised in-house IVDs to detect exotic infectious diseases or infectious agents that represent a possible biosecurity or public health threat. The risk that critical IVDs and services may be unavailable in Australia, particularly for donor screening, after the end of the transition period far outweighs the benefit of retaining the existing CA procedures for Class 4 in-house IVDs.

In addition to the compliance difficulties faced by commercial and in-house manufacturers of Class 4 IVDs, Australian manufacturers of Class 2 and 3 IVDs are currently disadvantaged under the new regulatory requirements compared to their overseas counterparts. Third party QMS CA evidence is accepted for overseas manufacturers of Class 2 and 3 IVDs however Australian manufacturers require a TGA QMS CA Certificate, regardless of whether they already hold third party CA certification (e.g., from a European notified body). This unnecessarily increases the regulatory burden and costs imposed on our Australian IVD manufacturers.

Proposal 3A: selective performance evaluation of Class 4 IVDs.

Under the current regulatory framework the TGA has no legal remit to request premarket performance evaluation of a Class 4 IVD to independently verify the manufacturer's performance claims. The TGA approval of a design examination certificate for a Class 4 IVD is solely reliant upon the evaluation of the evidence provided by the manufacturer. In many cases the performance of the product is well established on the global market and the manufacturer can provide appropriate supporting evidence. However, in particular instances, there may be a need for the TGA to seek additional assurance that the manufacturer's claims can be independently verified and that any potential risks associated with use of the product are outweighed by the benefits to both the individual and public health. Independent performance testing of a Class 4 IVD may be warranted to ensure that there is no additional risk to public safety in certain circumstances such as when there is a novel indication for use of a product or there is evidence to suggest that a new technology is significantly different to existing technology and the manufacturer has failed to provide adequate supporting evidence.

There was general support for the proposal to amend the Regulations to allow the TGA to reserve the right to undertake premarket performance evaluations for Class 4 IVDs although a number of respondents chose to withhold comment on this proposal. The commercial industry only supported the proposal with the caveat that this would not be a requirement for all Class 4 IVDs, and that the TGA should have sound reasons for requiring a performance evaluation.

Some industry members expressed concern that changing the current assessment process could be a disincentive for manufacturers and sponsors of Class 4 IVDs and could delay (as additional time would be required to perform the evaluation) or prevent innovative products being supplied in Australia. Industry would like the TGA to provide comprehensive guidelines on what products are likely to be selected for performance testing and consider the possibility of an option for a manufacturer to conduct their own studies to generate further evidence (as this may be quicker).

Many respondents noted that it is in the interests of public health and patient safety to have a regulatory framework that allows for selective performance evaluation of Class 4 IVDs, if deemed necessary, to ensure that the performance of these Class 4 IVDs meet appropriate standards.

Although overall those who provided a response were supportive of the proposal to introduce selective performance evaluation of Class 4 IVDs concerns were raised that the cost for the TGA to undertake the performance evaluation would be recovered through higher fees from all applicants. This is not the intention of this proposal. Manufacturers would be required to provide the test kits for evaluation however under this proposal they would not be charged any additional evaluation fees.

Proposal 3B: performance evaluation of all Class 4 IVDs.

There was very little support for the introduction of performance evaluation for all Class 4 IVDs to confirm that a product meets the manufacturer's intended purpose and performance claims. Supporters considered that TGA conducted performance testing would allow independent, impartial assessments of high risk IVDs under laboratory conditions on specimens sourced from an Australian population and would ensure the Class 4 IVDs available on the Australian market are of the highest quality. However, these concerns were not shared by others, particularly commercial industry, where it was considered that performance testing for all Class 4 IVDs would be excessive and should only be reserved, if necessary, for specific high risk products.

As with Proposal 3A, manufacturers would be required to provide the test kits for evaluation however under this proposal they would not be charged any additional evaluation fees.

Proposal 3C: retain the current assessment process (status quo).

Only two submissions indicated outright that they would prefer the current arrangements be retained. It was noted that manufacturers are already required to demonstrate that an IVD's analytical and clinical characteristics were appropriate for its intended use in Australia and that if the amendment were introduced it would add some uncertainty into timelines and requirements for approval of these IVDs.

A number of respondents chose not to comment on any of the proposals put forward in the consultation paper in relation to performance evaluations for Class 4 IVDs. Although the commercial industry was conditionally supportive of Proposal 3A in subsequent meetings it was made clear to the TGA that the preference was to maintain the status quo.

If the status quo was maintained the TGA would have no capacity to undertake independent performance testing of certain high risk IVDs (in relation to an applications for a design examination certificate) prior to their release on the Australian market. However, the TGA would still maintain the ability to undertake independent performance testing of specific high risk products in the postmarket environment, if required, to confirm the manufacturer's claims and ensure the quality, safety and performance of an IVD on the Australian market.

Proposal 4A: amend the definition of a medical device to include predisposition and susceptibility tests.

In recent years, technological advances have resulted in an increased availability of in vitro diagnostic genetic tests to detect molecular markers that can provide an indication of a person's predisposition or susceptibility to a particular disease or condition. Some of these tests are being marketed directly to the consumer without any form of medical supervision. The results from these tests can cause significant anxiety and stress, particularly if an increased risk of developing a disease or condition is identified.

These tests fall within the definition of a therapeutic good, but as they do not meet the definition of a medical device they are not subject to regulation as an IVD medical device. Without an amendment to the definition of a medical device, these IVDs (the majority of which are genetic tests) would continue to be exempt from the requirement to be entered in the ARTG and consequently would not be assessed for quality, safety and performance prior to release on the Australian market. If they are included, under the IVD framework, they would predominantly be classified as Class 3 IVDs and as such are considered to represent a moderate public health risk or high individual risk.

The majority of those consulted were supportive of the proposal to amend the definition of a medical device to include tests for predisposition and susceptibility to disease and considered that it was in the interest of both consumers and providers for these products to be regulated in a manner that reflects the level of risk they represent.

In support of this, it was noted that molecular genetic tests can have a significant impact on individuals and therefore these tests should be regulated in the same manner as other IVDs. It was also noted that any test for disease predisposition or susceptibility should be defined as a medical device, irrespective of the specific technology used for the test.

The amendment of the definition of a medical device to include these IVDs would correct an unintended oversight and ensure that that these products are regulated in a manner that reflects the level of risk they represent. The fees and charges applied would be comparable to other IVDs of the same risk rating.

Proposal 4B: retain the current the definition of a medical device (status quo).

There was very little support to retain the current definition as it was generally acknowledged that it was an unintended oversight that these products were not included in the definition of a medical device. If the status quo were maintained these IVDs would continue to be regulated under the pre-existing framework. The majority of these products would be exempt from the requirement to be entered in the ARTG and would not be subject to any premarket scrutiny, prior to supply on the Australian market, or post-market monitoring.

The few who did not support any amendment considered that there was a risk that if an equivalent level of assessment is applied to these IVDs that these products may be withdrawn from the Australian market as it may not be possible for sponsors to meet the regulatory requirements (and costs). However there is little evidence to support this being the case. The CHF's view is that there are significant potential ramifications for patients receiving the results of tests for predisposition and susceptibility to disease and that regulation is needed and justified.

As previously provided, these IVDs represent a moderate public health risk or high individual risk and therefore these tests should be required to demonstrate an adequate level of quality, safety and performance. The inability to regulate these tests appropriately under the IVD framework would result in the continued availability of products in Australia that would otherwise not meet minimum quality requirements.

Proposal 4C: retain the current definition of a medical device and issue a Therapeutic Goods Order that predisposition and susceptibility tests are not considered to be IVDs.

The impact of this proposal is similar to the impact of Proposal 4B. If these tests were declared not to be IVDs they would continue to remain exempt from any regulatory requirements and would not be subject to any premarket or post-market scrutiny.

The CHF's view is that there are significant potential ramifications for patients receiving the results of tests for predisposition and susceptibility to disease, particularly for genetic testing and that regulation is needed and justified.

Additionally, the TGA would need to provide the general public and health professionals with a warning about the risks of using and interpreting the results from these IVDs for clinical decision making. This would be likely to provoke comment and questions as to why these products are not subject to an adequate level of regulatory oversight commensurate with the level of risk they represent.

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