TGA have published their plans for the long awaited new regulatory framework for IVDs. This follows the consultations conducted as part of the proposed development of the Trans Tasman ANZTPA agency arrangements. The system will be based upon a conformity assessment model with risk based classifications determining the level of regulatory review. This regulation will be implemented by bringing IVDs within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002. This is a change in regulation without modification to the primary legislation in the Therapeutic Goods Act - there is no need to introduce a new bill and the change will be achieved by means of simply tabling the revision in parliament as a 15-day disallowable instrument. TGA plan to introduce the amendments into parliament in the third quarter of 2009 with implementation of the new system before the end of the year. As was the case for the introduction of the harmonised devices regulations, after implementation there will be a four year transition period before the new framework becomes mandatory.

Exemptions to end

Most IVDs are currently exempt from TGA regulation. This will change when the new classifications come into force. The classification and conformity assessment arrangements broadly mirror the European IVDD requirements, although the classification arrangements have some significant differences in the detail.  Click here for a detailed comparison of the new Australian and existing European IVDD classifications.

TGA/NATA joint oversight of in-house tests

Currently all in house tests – conducted entirely within a laboratory or lab network are outside of the scope of TGA regulation. Under the new arrangements TGA will require that all such tests be NATA accredited, and will directly assess the highest risk (Class 4) tests. TGA will also begin data sharing with NATA to police the new regulations.

Questions remain over third party assessment

Key questions remain about the implementation. In particular this change is set against the background of current consultation regarding implementation of third party conformity assessment in Australia. The current proposal for TGA keeps the requirement for direct TGA conformity assessment of Australian manufacturers of IVDs. However there are signs of movement. Interestingly the TGA proposal talks in terms of TGA or other acceptable manufacturer certification being required for the lower risk IVDs.

TGA have learned form the implementation of transitional arrangements from the introduction of the devices regulations. Fee structures will not penalise those manufacturers or sponsors who choose to transition early in the 4 year transition period, hopefully avoiding the last minute rush which overloaded the review capacity of TGA as the devices transition came to an end.