TGA Exemption of PHLN Network issued 20th March 2020
Exemption allows for immediate supply of COVID-19 tests
The Australian regulatory framework for medical devices allows National Association of Testing Authorities (NATA) accredited laboratories to develop and use their own laboratory developed tests (referred to as 'in-house' IVDs), without requiring those tests to be included in the Australian Register for Therapeutic Goods (ARTG). This has enabled Australian laboratories to immediately develop COVID-19 tests based on internationally available COVID-19 genomic information and to commence testing.
To support a rapid COVID-19 response, tests used to test for COVID-19 (COVID-19 tests) will be exempt from particular requirements of the Therapeutic Goods Act 1989. This emergency exemption allows commercial suppliers of COVID-19 tests to immediately supply their tests to laboratories within the Australian Public Health Laboratory Network (PHLN). Because the PHLN is well integrated in state and territory public health systems, this will help facilitate reporting, recording and tracing of the spread of COVID-19 infections.
Please note the exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care, other than to the laboratories specified in the exemption.
AM Diagnostics Approvals for Australian Market
The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.
The TGA regulates the supply of:
medicines prescribed by a doctor or dentist
medicines available from behind the pharmacy counter
medicines available in the general pharmacy
medicines available from supermarkets
complementary medicines, these include vitamins, herbal and traditional medicines
medical devices, from simple devices like bandages to complex technologies like heart pacemakers
products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
vaccines, blood products, and other biologics.
and the manufacturing and advertising of these products.
Information is from www.tga.gov.au/what-tga-regulates
AM Diagnostics is a registared sponsor for a number of products suitable for the Australia Market.
AM Diagnostics has current Registrations for the following Products that are listed on the ARTG
AM Diagnostics has a number of Applications awaiting approval for these products to be avaliable for the Australia Market please check back soon for our latest information on these products