The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010. The changes will be implemented on 1 July 2010, and serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes to TGA legislation pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs); the likely implications of which are described below.
In a press release dated 16 March 2010, the TGA explained the impetus for the amendment by citing the current, limited IVD regulation and also stating:
“The amended Regulations set out more comprehensive and consistent requirements for IVDs, including classifying IVDs according to their intended purpose and the public health and personal risks associated with their use… The new regulatory framework for IVDs will also harmonise Australia's regulation of IVDs with those recommended by the Global Harmonisation Task Force (the GHTF), whose members include the five major regulatory jurisdictions: the United States of America, Europe, Canada, Japan and Australia.”
This is the first IVD legislation which is adapted from GHTF IVD Guidance. The new classification of IVDs in Australia has been transposed from the GHTF to consist of Classes 1, 2, 3, and 4 in increasing order of risk. The Classification rules for IVDs will be inserted as Schedule 2A and explicit examples and descriptions are delineated therein. The new IVD classification scheme is summarized in the table at the end of this correspondence.
Further, the new regulations require that all IVDs to be placed on the Australian market must be registered prior to sale in the Australian Register of Therapeutic Goods (ARTG) as of 1 July 2010. Those products which are currently on the market and not registered will have until 2014 to do so; thus giving way to a 4 year transition period. It is only for IVDs new to the market, then, that the 1 July 2010 date of implementation applies.
For IVDs which didn’t require premarket registration approval and inclusion in ARTG and were marketed in Australia before 1 July 2010, evidence will be required to demonstrate that these devices were in fact on the Australian market before 1 July 2010, and therefore are entitled to a four year transition period. To this end, our understanding is that documents proving that the product had been sold or advertised prior to 1 July 2010 may constitute evidence of supply.
Based on our communication with the TGA, for Class 2 and Class 3 IVDs manufactured outside of Australia which were considered self-certified in the EU (according to the IVDD 98/79/EC) and thus don’t possess (and can’t) a European Notified Body issued CE marking certificate, ISO 13485:2003 certification may be considered an appropriate conformity assessment certificate suitable for the TGA. We should note however, that though ISO 13485 certification may serve as a conformity assessment suitable to the TGA, forthcoming guidance will likely clarify this point, and we will be sure to relay this information at that time. Class 3 IVDs which possess only ISO 13485 certification will be subject to a Technical File Review (TFR). Incidentally, manufacturers of foreign products (those outside of Australia) which do not have an IVDD or ISO 13485 certification must obtain a TGA Conformity Assessment Certificate.
In addition to the above, TFR will be compulsory for point-of-care IVDs and self-test IVDs. In the comings months, we anticipate guidance documents on IVD regulations to be issued by the TGA. This guidance will likely include specifics detailing to which IVDs this TFR selection will apply.
From our website, you can access the full medical device approval process charts.
Table 1.0 New IVD Classification Scheme
|1: no public health risk or low personal risk||general laboratory equipment , reagents, specimen receptacles and microbiological culture media|
|2: low public health risk or moderate personal risk||results are not expected to be used as sole determinant in diagnostic situation detection pregnancy ovulation, tests for sodium, ALT, LDH, ferritin, or folate|
|3: moderate public health risk or high personal risk||to diagnose serious infectious diseases where there is a risk of propagation in the community, to determine immune status or to monitor levels of medicines, substances or biological components, detecting red blood cell antigens and antibodies for determining suitability for transfusion or for non-red cell typing for the purposes of transplantation of tissue, personalized medicine, monitoring antibodies to HBV (eg HBe IgM, HBeAb), or syphilis (RPR), Typhoid, Q Fever, Chlamydia trachomatis, Neisseria gonorrhea, Neisseria meningitidis or Cryptococcus neoformans, diagnostic assay for CMV, Chlamydia pneumoniae, MRSA, immune status tests for Rubella or Toxoplasmosis; Enteroviruses, CMV and HSV in transplant patients; Huntington’s disease, cystic fibrosis, cardiac markers, cyclosporin, prothrombin time testing, Spina bifida or Down syndrome|
|4: high public health risk||screen for transmissible agents in blood, blood components, tissue for transfusion or transplantation, intended to detect the presence of or exposure to a transmissible agent that causes a serious disease with a high risk of propagation in the Australian population; blood grouping reagents used to determine high risk blood groups and assess suitability for transfusion or transplantation antibody screening tests and nucleic acid screening tests for HIV and HCV; Hepatitis B surface antigen tests; antibody screening tests for HTLVI & II; and syphilis serology tests antigen/antibody combination assays, antibody neutralisation tests for Hepatitis B, anti-HB-core, anti-HBs and any confirmatory immunoblot assays specific markers used to screen blood and tissue in selected populations. Examples include tests for Cytomegalovirus (CMV) IgG, dengue, malaria, West Nile virus and Parvovirus B19 NAT; ABO system [A (ABO1), B (ABO2) & AB (ABO3);] rhesus system [D (RH1), C (RH2), E (RH3), c (RH4), & e (RH5)]; Kell system (K), Duffy system [Fya (FY1) & Fyb (FY2)] and the Kidd system [Jka (JK1) & Jkb (JK2)]|