A new, more rigorous regulatory framework for IVDs in Australia has been in the pipeline since 2002. As we reported in December 2006, although not the original intention, it emerged that this regime would be implemented as part of the trans-Tasman joint therapeutic regulatory scheme being established under ANZTPA.
As part of the ANZTPA consultation process, in May 2006 a draft Medical Devices Rule setting out how medical devices would be regulated under ANZTPA was released. This draft Rule only addressed medical devices generally, not IVDs. On 24 April 2007, a revised draft Rule addressing commercial IVDs was released ("the IVD Revision Draft Rule") and public comment invited. A Plain English Guide to the IVD Revision Draft Rule is also available.
As we report in this edition of Insights, however, since the release of the IVD Revision Draft Rule the Australian and New Zealand Governments have announced that the introduction of ANZPTA has been suspended. Arguably, the regulation of IVDs in Australia is all dressed up but with nowhere to go. Depending on whether and, if so, when ANZTPA is revived, it may be that Australia considers implementing its own IVD reforms. Either way, it is likely that these reforms will draw upon the proposed ANZTPA regulation, which is outlined below.
Notwithstanding the Australian Government's interest in ANZPTA, you would think that it would be interested in filling this vacuum. IVD reform is long-awaited and of considerable importance to device manufacturers, importers and end users.
IVDs are various instruments, equipment, apparatus, reagents or control/calibrators that are used in vitro to test human samples. Australia's regulatory framework for IVDs, as set out in the Therapeutic Goods Act 1989 ("the TG Act") and Therapeutic Goods Regulations 1990, has not kept pace with advances in IVD technology over recent years. Current shortfalls include inadequacies in the pre-market assessment of new IVDs, levels of protection that do not appropriately reflect risk, and a lack of scrutiny for a large number of exempt IVDs.
IVDs are currently categorised as being Registrable, Listable or Exempt, and their level of regulation depends on this classification. Sponsors of Registrable IVDs must provide evidence of the safety, quality and efficacy before the product is registered on the Australian Register of Therapeutic Goods ("ARTG"). Sponsors of Listable IVDs need only provide evidence of GMP before being listed on the ARTG. Exempt IVDs, of which there are many, are not required to be entered on the ARTG.
A new medical device regulatory regime was introduced in Australia in October 2002. While IVDs technically fall within the definition of a "medical device" under the TG Act, they were specifically excluded from the trans-Tasman regime because the Australian Government proposed to create a separate framework for them.
Proposed regulation under ANZPTA
As set out in the IVD Revision Draft Rule and accompanying Plain English Guide, it was proposed that IVDs would be regulated as a subset of medical devices under ANZTPA. This new system was anticipated to broaden the scope of IVD regulation to fill gaps in the current system and bring Australia into line with international best practice. We note that some distinctions between medical devices and IVDs were to remain under ANZTPA to account for the specific features of IVDs.
Some key features of this regime are outlined below.
Control by licensing
ANZPTA would control the supply of therapeutic products, including IVDs, in Australia and New Zealand by product licensing.
Unless exempted, a medical device would only be able to be imported to, exported from or supplied in Australia or New Zealand by (or with written approval of) the holder of an ANZTPA product licence. Reasons why a medical device could be exempted include:
- it will be used in life-threatening or otherwise grave cases (where appropriate measures have been taken regarding obtaining patient consent and notifying ANZTPA)
- it is imported for the treatment of the importer or the importer's family
- it will be exported, but not for commercial supply; and
- it is imported, exported or supplied for the purpose of a regulatory submission, laboratory testing, or examination, demonstration or display.
The product licence would generally enable import into, export from and supply in both Australia and New Zealand. There may be exceptional circumstances in which one country has departed from the joint regulatory regime in respect of a certain product. In respect of these products, a single country licence would be granted.
Essential principles and standards
All IVDs would have to comply with certain essential principles relating to safety and performance before an ANZTPA licence can be obtained. There would be general principles which apply to all medical devices, for example, wide-ranging requirements regarding safety, design and construction. In addition, there would be particular principles for IVDs, including those relating to design, manufacture, performance and instructions. There would be flexibility as to how compliance with these principles can be demonstrated.
In addition to these principles, there would be medical device and manufacturing standards. Compliance with these standards will not be mandatory, but it is one way in which compliance with the essential principles can be established.
There are currently five classification levels for medical devices, based on the level of invasiveness, duration and location of use, and whether the device is powered.
If the new ANZTPA regime eventuates, IVDs will be separately classified into four classes. This separate classification would take into account the use of IVDs in establishing disease status, patient management, monitoring substances, genetic screening and diagnosis, cell and tissue typing and pregnancy and fertility testing. The classes would be:
- Class 1 IVDs - low personal risk
- Class 2 IVDs - low public health risk, moderate personal risk
- Class 3 IVDs - moderate public health risk, high personal risk; and
- Class 4 IVDs - high public health risk.
The classification would determine the level of conformity assessment required. Conformity assessment refers to the pre-market regulatory obligations of manufacturers. Higher-class devices would need to undergo more rigorous conformity assessment and will be required to have their quality management systems certified by ANZTPA.
In respect of Class 4 IVDs, ANZTPA would need to issue a conformity assessment certificate before a product licence can be granted. Certain conditions with which the manufacturer must comply may be imposed on this certificate. ANZPTA would have power to suspend or revoke this certificate.
ANZTPA proposes to put in place comprehensive post-marketing surveillance systems to ensure licensed products continue to comply with regulatory requirements. For example, it would undertake post-marketing compliance testing and audits. Manufacturers and sponsors of IVDs would also be required to actively monitor their product's performance and report adverse events.
Issues to be resolved
The IVD Revision Draft Rule only addresses "commercial", not "in-house" IVDs. In-house IVDs include:
- IVDs manufactured in-house and not supplied in a commercial context; and
- commercial IVDs that are being used for a clinical application other than that originally intended by the manufacturer.
It appears likely that the regulation of in-house IVDs would be incorporated into the regulatory framework at a later date.
Further, it is proposed that certain types of self-testing IVDs would be prohibited from supply. These include certain self-testing IVDs used to test blood and tissues, self-testing genetic tests and self-testing IVDs used to test for serious disorders such as cancer and myocardial infarction. The IVD Revision Draft Rule does not yet incorporate this prohibition.
If introduced, the new regime looks set to substantively change how IVDs are regulated in Australia and, assuming the ANZTPA is formalised, New Zealand. IVD manufacturers and sponsors would need to determine which new legal requirements are relevant to their IVDs, taking into account the new classification scheme.
It seems however that ANZTPA, including the new IVD regulation, will not become operational until at least 2008, if at all in its current form. It remains to be seen whether the Australian Government will push ahead with IVD reforms to the TG Act in the meantime.
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