Proposed delay of various regulatory reforms
The Australian Government is proposing to delay the commencement of a number of planned medical device regulatory reforms. This proposal reflects the challenges identified by the medical device industry and healthcare professionals as they have focused on the COVID-19 crisis.
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 would be amended to delay implementation of the reforms from August 25, 2020 to:
- November 25, 2021 for reclassification of certain devices
- February 25, 2021 for software as a medical device (SaMD)
- February 25, 2021 for personalized medical devices (including 3D-printed devices)
- November 25, 2021 for systems or procedure packs
Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be delayed for up to two years after the commencement of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). They would thus likely go into effect in May 2023, or May 2024 if IVDR implementation ends up being delayed for one year.
The delay to the amendments is intended to provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context in order that the transition in Australia may be implemented effectively.
Related resources on Australian medical device regulation:
- Australia emergency use pathways for medical devices
- Australian TGA medical device registration consulting
- Australian TGA Sponsor in-country representation
- Process chart: Australian TGA regulatory approval process
- Whitepaper: Medical device registration in Australia and New Zealand