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TGA

Australian medical device regulators preparing Brexit contingency plans

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market.
  • TGA will continue recognizing conformity assessments from UK-based Notified Bodies for existing and new ARTG listings and applications.
  • Short-term effects of a potential orderly or no-deal Brexit should be minimized by TGA measures as described.

Australia TGA Clarification on IVD Audits

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations, adopting a risk-based classification system. Under the new system, many IVDs will be subject to more rigorous controls, including random and mandatory audits. TGA has now published multiple IVD guidance documents.

The TGA has most recently issued guidance outlining several key points regarding IVD application audits (Technical File Review), including:

Australian TGA Updates IVD Regulations

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.