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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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The issues

A number of issues were identified by the various members of the IVD sector (laboratories, industry and bodies or individuals associated with the IVD sector) during the first two years (July 2010 - July 2012) of the transition period for the new regulatory framework for IVDs.

Issue 1 - Timeframe for valid applications for inclusion in the ARTG

  • Under the original provisions of the new regulatory framework valid applications for inclusion of all commercial IVDs and Class 4 in-house IVDs in the ARTG were required to be lodged with the TGA by 30 June 2014. Any IVDs that did not meet this requirement could not be legally supplied in Australia after this date.
  • Manufacturers of IVDs (both commercial and in-house) were experiencing difficulties providing sufficient documentary evidence to demonstrate compliance with the new requirements resulting in a slower than expected rate of transition to the new framework.
  • Any applications for a TGA CA received late in the transition period may not have been assessed in time to meet the required 30 June 2014 deadline as the legislated timeframe for evaluation of an application for a TGA CA including a design examination is up to 255 TGA working days.
  • Additionally, many in-house IVDs ‘manufactured’ by laboratories are developed by modification of commercial IVDs. Laboratories cannot comply with the requirements until they can ascertain that the commercial IVD on which an in-house IVD is based has, or will be, included in the ARTG.

Issue 2 - Regulatory requirements for Class 4 IVDs and Australian manufactured Class 2 and 3 IVDs

  • Manufacturers of Class 4 IVDs (both commercial and in-house) and Australian manufacturers of Class 2 and 3 IVDs are experiencing difficulties complying with the new regulatory requirements and meeting the associated costs. Commercial industry and laboratories consider that the requirements unnecessarily duplicate work and the high regulatory costs are prohibitive, creating a disincentive to supply products and services in Australia, particularly Class 4 in-house IVDs for donor screening of organ and tissue.
  • Under the new IVD Regulations, any test used for donor screening is considered to be a Class 4 IVD. Laboratories that develop Class 4 in-house IVDs are subject to the same requirements as commercial Class 4 IVDs and will need to obtain TGA CA Certificates for their quality management systems (QMS) and separate certificates for each Class 4 in-house IVD. As part of the application for CA certification, a laboratory must be able to demonstrate that both the Class 4 in-house IVD and the processes used to manufacture it conform to the requirements of the therapeutic goods legislation.
  • Currently in Australia there is a lack of suitable commercial serology IVDs available that are intended for use in screening cadaveric samples from tissue donors for infectious diseases. To comply with the mandatory donor screening requirements laboratories have developed Class 4 in-house IVDs, by modifying an existing commercial IVD intended for screening live donors, for use on cadaveric samples. Where a suitable commercial alternative is unavailable laboratories have also modified commercial IVDs to perform supplemental donor screening, both live and cadaveric, for additional infectious diseases such as malaria. These are also considered to be Class 4 in-house IVDs. Laboratories modifying commercial IVDs are unable to comply with the requirements for Class 4 in-house IVDs as they have no control over the design and manufacturing processes for the commercial IVD and can only provide technical documentation to support the modification they have made.
  • In addition, certain de novo Class 4 in-house IVDs have been developed by laboratories where a suitable commercial IVD has been unavailable. These are typically low volume but nonetheless critical tests used in very specific circumstances (e.g., Class 4 in-house IVDs to detect very weak or uncommon antigens in blood that could potentially cause a significant transfusion reaction in the recipient). It is proving difficult for laboratories to provide the required technical documentation for these tests as the relative ‘rareness’ of the condition means that there is a lack of suitable specimens available to perform an extensive evaluation.
  • There are approximately 5 eye banks and 30 tissue banks in Australia representing a large proportion of the transplantation sector.4 In 2012 there were 3,843 tissue donors with an increased number of tissue and whole organ donations coming from deceased donors (5% of tissue donations came from deceased donors in 2012).5,6 In the transfusion sector, the Australian Red Cross Blood Service (ARCBS) supplied 801,295 units of donated red blood cells in 2011/2012.7 In addition, there is also an extensive network of cord blood banks in Australia, with the Sydney Cord Blood Bank alone having reportedly collected over 10,000 cord blood units for potential stem cell transplantation.8 Donor screening testing to support these types of facilities and services is provided by the ARCBS and at least 10 other Australian laboratories.
  • These laboratories have indicated that they will be unable to comply with the new regulatory requirements or meet the associated costs for their Class 4 in-house IVDs and as a result may cease to provide donor screening services. There is a threat to the continued supply of Australian blood and other biological products (e.g., donor organs, corneas, bone grafts, heart valve transplants, blood components) for transplantation and transfusion.
  • Tissue from Australian cadaveric donors will possibly be no longer available for transplantation in Australia generating a reliance on tissue products from overseas manufacturers. Under the current Regulations donor screening tests (IVDs) used by overseas manufacturers of tissue products are not required to meet the new IVD regulatory requirements whereas Australian tissue manufacturers must comply. This would disadvantage Australian tissue manufacturers and Australian recipients of donor tissue could be exposed to potentially less regulated overseas manufactured tissue products.
  • The Australian market represents a very small proportion of the global market for IVDs and approximately 95% of commercial IVDs supplied in Australia are manufactured overseas.9 Australian commercial manufacturers of Class 2 and 3 IVDs, the majority of which are small businesses, are required to obtain a TGA CA Certificate for their QMS regardless of whether they already hold CA certification from a European notified body. This imposes an additional regulatory burden and cost on Australian manufacturers who want to supply their products both overseas and within Australia. In comparison, overseas manufacturers of Class 2 and 3 IVDs do not require a TGA CA Certificate and sponsors can supply these products in Australia based on third party CA certification (e.g., from a European notified body).

Issue 3 - Performance evaluations for Class 4 IVDs

  • Prior to the commencement of the new IVD framework, IVDs for HIV and HCV testing required registration in the ARTG. The pre-2010 Regulations required practical laboratory performance testing of sample IVDs (for HIV and HCV) to be undertaken as part of the assessment of applications for registration to confirm that a product meets the manufacturer’s intended purpose and performance claims.
  • Under the new framework the TGA does not hold a legislative remit to reserve the right to undertake performance testing of Class 4 IVDs submitted for design examination CA certificates. Consequently performance testing results cannot be taken into consideration by the TGA when making a decision with respect to an application for design examination CA certificates.

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

  • IVDs used to determine predisposition or susceptibility to a disease or condition are defined as 'other therapeutic goods' under Part 3-2 of the Act and not as a medical device under section 41BD of the Act. This means that, in the Act, these tests fall within the definition of therapeutic goods, but are not captured in the definition of a medical device as IVDs intended to diagnose susceptibility to disease.
  • Consequently, these IVDs, the majority of which are genetic tests, would continue to be regulated under the pre-existing framework and, the majority of these products would be exempt from the requirement to be entered in the ARTG and premarket scrutiny which is inconsistent with other IVDs (with a comparative level of risk).
  • The omission of these products from the definition of a medical device appears to have been a simple oversight as the inclusion of genetic testing was clearly articulated in the 2004 regulatory impact statement for the introduction of the new IVD regulatory framework.

Footnotes

  1. Organ and Tissue Authority, July 2011, Report on the options for more effective eye and tissue retrieval, processing and storage, Organ and Tissue Authority, Canberra.
  2. Organ and Tissue Authority, 2012, Tissue Report, Organ and Tissue Authority, Canberra.
  3. Organ and Tissue Authority, June 2013, Performance Update, Organ and Tissue Authority, Canberra.
  4. Australian Red Cross Blood Service, 2011-2012, Annual Report, Australian Red Cross Blood Service, Melbourne.
  5. Sydney Children's Hospital - Sydney Cord Blood Bank. 2013. Viewed 24 October 2013. <www.schn.health.nsw.gov.au>.
  6. Therapeutic Goods Administration, September 2009, Regulation of in vitro diagnostic devices – Cost Recovery Impact Statement, TGA, Canberra.

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