Following extensive industry dialogue, TGA extended to 2015 the timeframe for transition to the regulatory framework for commercial IVDs, and later for in house IVDs. However there are some important exclusions – especially for currently uncertified, unregistered, Commercial Class IV IVDs, where urgent action is required to avoid a prohibition from sale.
The 11th hour amendment of the transition regulations provided for extension of deadlines as follows:
- 31 August 2014 for Submission of applications for Conformity Assessment
- 30 June 2015 for Submission of ARTG registrations for all Commercial IVDs
- 30 June 2016 for Conformity Assessment applications for in-house Class 4 IVDS
- 30 June 2017 for Submission of ARTG registrations for all in-house Class 4 IVDS
Note that for Class 4 IVDs, it’s essential to file a conformity assessment application by August 31 2014. Otherwise they will be considered to be New Applications and hence prohibited from sale until included in the register.
Also note that TGA states: “The new transitional provisions do not apply to any product that was supplied prior to 1 July 2010 and since this date, has been the subject of an application for inclusion in the Australian Register of Therapeutic Goods (ARTG) under Chapter 4 of the Therapeutic Goods Act 1989 that was rejected. These products cannot be legally supplied after 30 June 2014 unless they are included in the ARTG.”
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