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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
IVD market in Australia
IVDs are pathology tests and related instrumentation used to carry out testing on human samples. IVDs are typically used in diagnostic pathology laboratories, other laboratories (blood and tissue screening laboratories), at point of care, and in some cases, in the home. The results of these tests (IVDs) are intended to assist in clinical diagnosis and management of patient treatment. It is estimated that the results obtained from pathology tests are responsible for 70% of all medical diagnoses and 100% of all cancer diagnosis and make a significant contribution to the management of disease1. The results obtained from IVDs also play an essential part in screening and prevention programs to improve overall public health.
For the purposes of regulation, IVDs fall into two categories: commercial IVDs and in-house (laboratory developed) IVDs. An in-house IVD is a test that has been developed in a laboratory for use within that laboratory (an IVD not commercially supplied for use outside that laboratory). Commercially supplied IVDs that have been modified by a laboratory are also considered to be an in-house IVD.
In 2003 the TGA commissioned a survey of the IVD market in Australia, for the purpose of preparing the initial RIS for the introduction of the new IVD regulatory framework2. The survey identified over 43,000 different types of commercial IVDs available for sale in the Australian market and found that:
- more than 95% of the IVDs supplied to the Australian market are imported
- locally manufactured IVDs accounted for less than 5% of IVDs supplied to the Australian market
- the majority of Australian manufacturers rely on exports to recoup development costs (most local manufacturers are small business).
At the time of the survey the European Device Manufacturers’ Association estimated that the Australian market accounted for only 1.25% of global sales of commercial IVDs. This situation is unlikely to have changed substantially in the intervening period.
The number of commercial businesses engaged in supplying IVDs to pathology laboratories in Australia was estimated to be approximately 160. Further information provided by an industry peak body in 2009 estimated that the number of suppliers had reduced to less than 80 through consolidation of commercial businesses. Additionally, the majority of suppliers would be classified as small business with 43% indicating that they employed 10 or less people and had a turnover between $1m and $5m. Many of these businesses are distributors.
The TGA commissioned survey also identified at least 640 laboratories that were involved in pathology testing in Australia and of these 48% developed in-house IVDs. In contrast, a more recent survey (September 2013) undertaken by the TGA found that at least 86% of responding laboratories develop some form of in-house IVD. Respondents indicated that in-house IVDs were predominantly developed to address a particular need or where there was no suitable commercial alternative (e.g. specialised genetic tests for rare conditions, tests for uncommon zoonotic infections, or cadaveric donor screening).
The new regulatory framework for IVDs
The new framework for IVDs was introduced to ensure that IVDs undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use. Under the framework, IVDs are regulated as medical devices and, unless exempt, all IVDs were required to comply with these requirements from 1 July 2014 (at the end of a four year transition period).
The framework has the following features:
- a 4-tier classification schema (Class 1-4 IVD) based on different levels of risk for each class of device, with Class 4 being the highest risk classification (the 4-tier classification schema is described in Appendix 1)
- a requirement that all commercial IVDs and Class 4 in-house IVDs (those IVDs developed or modified by providers for use in their own laboratories, also see definition of 'in-house IVD' provided in Appendix 2 - Acronyms and Glossary) for therapeutic use were to be included in the Australian Register of Therapeutic Goods (ARTG) from 1 July 2014
- a requirement that all IVDs comply with a set of Essential Principles (EP)s for quality, safety and performance
- conformity assessment (CA) procedures, based on risk classification, to be applied by manufacturers to demonstrate initial and on-going compliance with the EPs and
- provisions for post-market monitoring, including compliance testing, adverse event reporting and recall procedures.
Regulation of IVDs prior to the introduction of the new regulatory framework
Prior to 1 July 2010, commercial IVDs were regulated as diagnostic goods for in vitro use under Parts 3-2 and 3-3 of the Act in conjunction with the Therapeutic Goods Regulations 1990. Tests for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) were required to be registered in the ARTG. Tests for home use (pregnancy tests and glucose monitoring kits), tests that include human origin material, blood collection tubes or diagnostic goods for in vitro use that were listed on the Pharmaceutical Benefits Scheme (PBS) were all required to be listed in the ARTG. All other IVDs, including all in-house IVDs3, were exempt from regulation.
All IVDs listed, registered, or currently exempt from entry in the ARTG under the pre-existing framework were considered to be transitioning products and did not require inclusion in the ARTG under the new framework until after 30 June 2014. However, any new commercial IVDs introduced to the Australian market after commencement of the transition period on 1 July 2010 have been required to be in the ARTG prior to supply.
2004 regulation impact statement
In 2003 the Australian Health Ministers’ Advisory Council (AHMAC) asked the TGA to address the level of regulatory oversight of in-house IVDs. From the earliest discussions on the development of a new regulatory framework for IVDs it was intended that in-house IVDs would be subject to the new requirements.
Public consultations on the regulation of IVDs were conducted and a RIS was prepared for the new regulatory framework in January 2004. The RIS considered several options for the regulation of in-house IVDs, including:
- Options 1 and 2 - no regulation of in-house IVDs
- Option 3 - regulating all in-house IVDs on the same basis as commercial IVDs
- Option 4 - regulating high risk in-house IVDs (including tests for screening blood and tissues for transmissible infectious diseases) on the same basis as high risk commercial IVDs, and subjecting low risk in-house IVDs to an approved validation standard.
Option 4 was recommended in the 2004 RIS. AHMAC and the Australian Health Ministers’ Conference (AHMC) considered the RIS and agreed with the recommendation that Option 4 would sufficiently address the concerns of industry about inequities in regulation of both commercial and in-house IVDs.
What's in and what's out of the IVD framework?
Under the framework that came into effect on 1 July 2010 IVDs are regulated under Chapter 4 of the Therapeutic Goods Act 1989 (the Act) and the Regulations. The framework encompasses both commercially manufactured IVDs as well as in-house IVDs.
All IVDs, whether previously (prior to 1 July 2010) registered, listed or exempt (under the pre-existing framework) were to be regulated under the framework from 1 July 2014. This includes tests for serious infectious diseases, tests for screening blood, tissues and organs and cellular products for safety and compatibility, pregnancy tests, glucose monitors, and genetic tests (with the exception of those such as kinship testing that do not have a therapeutic purpose and therefore do not fall within the remit of the Act). Under the original provisions of the framework from 1 July 2014 all commercial IVDs and Class 4 in-house IVDs were required to be included in the ARTG.
However, IVDs used to determine predisposition or susceptibility to a disease, or a condition, are currently defined as ‘other therapeutic goods’. This means that these tests are not captured in the definition of a medical device and therefore are not regulated under the new framework and do not require inclusion in the ARTG.
International regulation of in-house IVDs
The new framework largely reflects the philosophies and recommendations of the Global Harmonization Task Force (GHTF) on medical devices, thereby ensuring that Australian regulatory practice is consistent with the directions of the global regulatory community.
That said, the GHTF guidelines do not specifically refer to the regulation of in-house IVDs, and at the present time the majority of other overseas regulators exclude these from the requirements of their regulatory frameworks.
To date, the US is the only other jurisdiction to substantively regulate in-house IVDs. While "laboratory developed tests" (the designation given to in-house IVDs) are currently exempt from review by the US Food and Drug Administration (FDA), they are nevertheless regulated under the provisions of the Clinical Laboratory Improvement Amendment 1988, that established quality standards for, and oversight of all laboratories conducting testing on human specimens for the diagnosis, prevention or treatment of disease. The FDA has also promulgated regulations covering Analyte Specific Reagents (ASRs), which are often used as the basis of laboratory developed IVDs.
On 26 September 2012 the European Commission (EC) released a proposal for new IVD Regulations that will replace the current In Vitro Diagnostic Medical Devices Directive (IVDD). The Regulations are to include requirements for in-house IVDs that ensure a higher level of safety and performance for high risk IVDs, irrespective of their place of manufacture. The EC proposal requires approval by the European Parliament and Council and is expected to be adopted in 2014-2015, with a five year transition period.
- Australian Association of Pathology Practices Inc, 2008. Viewed 17 March 2014. <http://pathologyaustralia.com.au/wp-content/uploads/2013/03/Pathology-in-Australia.pdf>
- Therapeutic Goods Administration, September 2009, Regulation of in vitro diagnostic devices – Cost Recovery Impact Statement, TGA, Canberra.
- An in-house IVD is a laboratory developed test. Full definition provided in Appendix 2.