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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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Proposals

As a result of the broader consultation process a number of proposals to address the problems with the new regulatory framework for IVDs were developed for consideration. The proposals are outlined here.

Issue 1

A proposal to extend the timeframe for transition to the IVD framework was put forward in the consultation paper and received broad support from stakeholders throughout the consultation process. Although it is expected that an extension to the timeframe would have a beneficial impact on industry and health outcomes, the proposed regulatory change was not considered (by the Office of Best Practice Regulation) to be sufficiently significant to require further examination in this RIS. Therefore the proposal to extend the transition timeframe was addressed by the TGA through a separate process. Affected stakeholders were notified of the amendments to the Regulations, in relation to the new extended timeframes, when the amendments were registered.

Issue 2

For the consideration of the following proposals the TGA regards in-house IVDs as those that can be developed de novo (e.g., from first principles or a published source) or by modifying a commercial IVD (modification to a commercial IVD includes using an IVD for a purpose other than that intended by the manufacturer).

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

Proposal 2A provides that a modified CA procedure would only be applied to certain Class 4 in-house IVDs predicated on registered commercial IVDs where the modification would not be considered to represent fundamental changes to the design of the IVD. Class 4 in-house IVDs that have undergone modifications affecting the components or design of the commercial IVD, or have been developed either from published sources or first principles (de novo) would be required to undergo a full CA process, similar to that currently in place and applicable to commercial Class 4 IVDs.

Laboratories using Class 4 in-house IVDs predicated on a registered commercial IVD would be required to:

  • maintain a Good Manufacturing Practice (GMP) licence or
  • National Association of Testing Authorities, Australia (NATA)accreditation as a medical testing laboratory demonstrating compliance with the international standard ISO 15189 (Medical laboratories – Particular requirements for quality and competence) and demonstrate compliance with the National Pathology Accreditation Advisory Council (NPAAC) standard Requirements for the Development and Use of in-house In Vitro Diagnostic Devices (IVDs).

Where these conditions were met, a CA would consist primarily of an evaluation by the TGA of the adequacy of the data validating the quality, safety and performance of the Class 4 in-house IVD in its modified state/setting and compliance with the EPs. Once approved, the Class 4 in-house IVD would be required to be included in the ARTG.

Laboratory manufactured de novo Class 4 in-house IVDs would still remain subject to the same CA procedures as commercial Class 4 IVDs. There would be no changes to the regulatory requirements for commercial Class 4 IVDs and Australian manufacturers of Class 2 and 3 IVDs.

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

A modified CA procedure would apply to all Class 4 in-house IVDs, including those developed de novo or modified from a registered commercial IVD.

The application of this modified CA procedure would be risk based, with the level of evaluation determined by the origin of the IVD (i.e. de novo versus modified commercial IVD). For an in-house IVD based on a registered commercial IVD the extent of the modification(s) would determine the level of evaluation required.

The laboratory would be required (as with proposal 2A) to maintain a GMP licence or NATA accreditation as a medical testing laboratory (and demonstrate compliance with the NPAAC standard). In addition to this the laboratory would need to provide validation data for the Class 4 in-house IVD to the TGA for evaluation of compliance with the EPs.

Where these conditions were met, CA would consist primarily of an evaluation by the TGA of the data validating the performance of the Class 4 in-house IVD. Inclusion in the ARTG would not be required however the TGA would maintain a database of the approved Class 4 in-house IVDs.

would be no changes to the regulatory requirements for commercial Class 4 IVDs and Australian manufacturers of Class 2 and 3 IVDs.

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

Proposal 2C has been developed following the consultation process and proposes a modified CA procedure that could be applied to:

  • Class 4 in-house IVDs (regardless of whether they have been developed de novo or from modification to a commercial IVD)
  • commercial Class 4 IVDs (both Australian and overseas manufacturers) and
  • Australian commercial manufacturers of Class 2 and 3 IVDs.

Commercial and laboratory manufacturers of IVDs applying for this procedure would be required to provide the TGA with an acceptable QMS CA certificate as evidence of a QMS. It would no longer be an absolute requirement to obtain TGA QMS CA Certificates prior to inclusion in the ARTG.

As with proposals 2A and 2B laboratories would be required to maintain a GMP licence or NATA accreditation as a medical testing laboratory (as evidence of an acceptable QMS for the manufacture of Class 4 in-house IVDs). Commercial manufacturers of Class 4 IVDs would be required to provide acceptable third party evidence of a QMS (i.e., QMS CA certification from a European notified body).

Where these conditions were met, the 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. The evaluation fee would be determined according to the level of evaluation and effort required by the TGA.

All Class 4 IVDs (both commercial and in-house) would require inclusion in the ARTG unless they qualified for an exemption. An exemption would allow IVDs to be supplied for special or experimental purposes in certain circumstances and would be subject to specific conditions.

Third party QMS CA Certification would be accepted for Australian commercial manufacturers of Class 2 and 3 IVDs as a basis for inclusion in the ARTG. However, certain Class 2 and Class 3 IVDs would be subject to an application audit consistent with the current regulatory requirements for overseas manufacturers of certain Class 2 and 3 IVDs.

For manufacturers who require or would prefer a TGA-issued conformity assessment certificate it is proposed that applications for conformity assessment and inclusion in the ARTG could be processed simultaneously to minimise the delay to market.

Proposal 2D: retain the current regulatory framework for Class 4 in-house IVDs (status quo).

No changes would be made to the new regulatory framework for IVDs. All Class 4 in-house IVDs would be subject to the same regulatory requirements as commercial Class 4 IVDs.

Issue 3

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

The Regulations would be amended to allow the TGA to reserve the right to undertake performance evaluation of any Class 4 IVD. Performance evaluation would not be undertaken routinely, but would be determined according to the level of risk represented by the type of IVD, the intended purpose, the performance claims made the manufacturer, and the technology used.

outcome of the performance evaluation could then be taken into account when making a decision on an application for a design examination CA certificate.

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

The Regulations would be amended to allow the TGA to undertake performance evaluation of all Class 4 IVDs (irrespective of the level of risk). The outcome of the TGA performance evaluation would be taken into account when making a decision on an application for a design examination CA certificate.

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

No changes would be made to the legislative remit to allow performance evaluations of Class 4 IVDs to be undertaken (particularly for those submitted for a design examination CA Certificate).

Issue 4

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

The definition of a medical device would be amended to include IVDs used to determine predisposition or susceptibility to a disease or condition. These IVDs would therefore no longer be defined as 'other therapeutic goods' under Part 3-2 of the Act and would instead be subject to the requirements of the new IVD Regulations.

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

No changes would be made to the definition provided in the Act. IVDs to determine predisposition or susceptibility to disease would continue to be regulated as 'other therapeutic goods'.

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.

No changes would be made to the definition provided in the Act. IVDs to determine predisposition or susceptibility to disease would continue to be regulated as 'other therapeutic goods' and would not be subject to premarket scrutiny for quality and performance. To clarify the TGA would issue a Therapeutic Goods Order declaring that predisposition and susceptibility tests are not IVDs.

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