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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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As demonstrated above, there are issues associated with new regulatory framework for IVDs and amendments are required to ensure the continued availability of IVDs, particularly critical Class 4 in-house IVDs, in Australia after the end of the transition period. In considering the issues every effort is being made to ensure that stakeholders are less likely to be disadvantaged by the introduction of the framework at the end of the transition period while the Australian population benefit from the supply of IVDs that are regulated in a manner that reflects the level of risk they represent.

It is was also recognised that there are uncertainties surrounding the costs with most of the proposals but that the financial and regulatory burden will be eased for most stakeholders when the transition timeframe is extended and if a modified CA procedure is introduced for Class 4 IVDs and Australian manufacturers of Class 2 and 3 IVDs.

Preferred proposals

The preferred approach to resolve the issues is to make a number of amendments to the framework. The following recommendations (which address each issue) have been informed by the impact analysis of all the information that has been provided to the TGA by stakeholders for this RIS.

Issue 1: Timeframe for valid applications for inclusion in the ARTG.

An extension to the timeframe for transition to the new IVD framework was the most suitable proposal for all stakeholders and has been addressed outside the RIS process.

Issue 2: Regulatory requirements for Class 4 IVDs and Australian manufacturers of Class 2 and 3 IVDs.

Modifying the CA procedure for the regulation of all Class 4 IVDs and Australian manufactured Class 2 and 3 IVDs (Proposal 2C) is recommended as it will reduce the regulatory burden on commercial IVD manufacturers and testing laboratories. It will increase their capacity to comply with the requirements while still maintaining an appropriate level of regulatory oversight without compromising the health and safety of Australians.

It will, importantly, ensure the continued availability of Australian manufactured human biological products for transfusion and transplantation. In addition the ability, in specific circumstances, to exempt IVDs from inclusion in the ARTG will ensure the continued supply of low volume, specialised Class 4 in-house IVDs (predominantly de novo) for special or experimental purposes.

It was agreed by most of those consulted that the regulation of commercial Class 4 and Class 4 in-house IVDs should be proportionate, cost-relevant, non-duplicative and designed to balance the safety of Australians with timely access to appropriate technologies.

Proposal 2C resolves many of the residual concerns expressed regarding the capacity to meet the regulatory requirements and associated fees for Class 4 IVDs, particularly Class 4 in-house IVDs where there are currently no commercial alternatives, and Australian manufacturers of Class 2 and 3 IVDs.

It is anticipated that the additional concerns raised by stakeholders during the consultation process regarding the ability of laboratories to comply with the requirements for Class 1-3 in-house IVDs and ensuring that the TGA retains responsibility for determining what is a Class 3 IVD will be addressed in conjunction with the amendments proposed under Proposal 2C.

Issue 3: Performance evaluations for Class 4 IVDs.

The analysis of the submissions and subsequent discussions with stakeholders found that Proposal 3C, retain the current assessment process (status quo), was the preferred proposal supported by the majority of stakeholders and therefore no regulatory amendments are required.

It is noted that the TGA has now progressed a significant way through the transition period and to date no safety issues or concerns have arisen as a consequence of not being able to undertake performance testing for Class 4 IVDs. The TGA has considered whether public safety would be impacted and has come to the conclusion that that it would not be, as the TGA will maintain the ability to undertake performance testing of Class 4 IVDs in the postmarket environment. Additionally, proceeding with performance evaluations for Class 4 IVDs would be ‘out-of-step’ with the regulation of medical devices as a whole and potentially create some uncertainty for the non-IVD medical device industry as to whether premarket performance evaluations would be expanded to capture all high risk medical devices.

Issue 4: Amend the definition of a medical device to include predisposition and susceptibility tests.

Proposal 4A, amending the definition of a medical device to include predisposition and susceptibility tests is preferred as it best meets the safety and public health objectives of the TGA, as well as correcting an unintended oversight in the legislation.

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