A
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Team:
I just received this notification which I found worth sharing here at the cove. Actually I am just copying a portion because there was some publicity related involved, so I tried to keep only the part w/o such commercial claims:
"We are writing to communicate three important changes to the Australian medical device and IVD regulatory landscape. Each of these items will be discussed in greater detail in the sections we’ve outlined below. They include:
1. IVDs are now regulated by the Australian Therapeutic Goods Administration (TGA)
2. Extensive new TGA guidance on medical devices has been issued
3. The process of changing Australian Sponsors has been simplified
TGA Regulates IVDs effective 1 July 2010
IVDs will now be regulated by the TGA. Though 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. These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs). The greatest implications of which include IVD classification based on risk and the first regulatory implementation of GHTF IVD Guidance.
To this end, the new classification of IVDs has been transposed from the GHTF to consist of Classes 1, 2, 3, and 4 in increasing order of risk. Further, the new regulations require that all IVDs be registered in the Australian Register of Therapeutic Goods (ARTG) prior to sale after 1 July 2010. Those products which are currently on the market and not in the ARTG, (as they were previously considered unregulated) will have until 2014 to do so; thus providing a four year transition period. For these products eligible for the four year transition period, it is our understanding (based on communication with the TGA) that documents proving that the product had been sold or advertised prior to 1 July 2010 may constitute evidence of supply. The 1 July 2010 implementation date applies only to IVDs that are new to the market."
I just received this notification which I found worth sharing here at the cove. Actually I am just copying a portion because there was some publicity related involved, so I tried to keep only the part w/o such commercial claims:
"We are writing to communicate three important changes to the Australian medical device and IVD regulatory landscape. Each of these items will be discussed in greater detail in the sections we’ve outlined below. They include:
1. IVDs are now regulated by the Australian Therapeutic Goods Administration (TGA)
2. Extensive new TGA guidance on medical devices has been issued
3. The process of changing Australian Sponsors has been simplified
TGA Regulates IVDs effective 1 July 2010
IVDs will now be regulated by the TGA. Though 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. These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs). The greatest implications of which include IVD classification based on risk and the first regulatory implementation of GHTF IVD Guidance.
To this end, the new classification of IVDs has been transposed from the GHTF to consist of Classes 1, 2, 3, and 4 in increasing order of risk. Further, the new regulations require that all IVDs be registered in the Australian Register of Therapeutic Goods (ARTG) prior to sale after 1 July 2010. Those products which are currently on the market and not in the ARTG, (as they were previously considered unregulated) will have until 2014 to do so; thus providing a four year transition period. For these products eligible for the four year transition period, it is our understanding (based on communication with the TGA) that documents proving that the product had been sold or advertised prior to 1 July 2010 may constitute evidence of supply. The 1 July 2010 implementation date applies only to IVDs that are new to the market."
