As the medical and healthcare sectors remain firmly focused on tackling the many and ongoing challenges of COVID-19, the Australian Government has announced that it will push back the commencement of a number of medical device reforms originally planned to commence at the end of this month.
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 (Cth) was passed in December last year and contained amendments that formed part of a package of reforms planned for the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). These amendments particularly looked to address changes in the medical devices industry that have come about in the years since those regulations were first drafted, including in relation to programmable medical devices and software as a medical device, the reclassification of certain devices and reforms to the regulation of personalised medical devices – an area which continues to see technological advancement.
Following the announcement from the Australian Government, the amendments are now slated to commence in a staged approach across the next few years:
- 25 August 2020 – amendments to the definition of ‘system or procedure pack’ will proceed as planned.
- 25 February 2021 – new classification rules will be introduced for medical device software to reflect the potential for devices to cause harm as a result of providing incorrect information, along with changes to the scope of the existing definition of ‘custom-made medical device’ to effectively limit the range of personalised medical devices that will be able to benefit from the exemption to registration on the Australian Register of Therapeutic Goods.
- 25 November 2021 – six medical device categories will be reclassified as part of an alignment with the European Medical Device Regulations. Additional changes related to systems or procedure packs will also come into effect at this time.
On a separate but related note, changes to the Essential Principles in the Australian Medical Regulations, and the implementation of such changes, have also been delayed and are now expected to come into effect two years after the commencement of the changes to the European Union Medical Device Regulation. The Therapeutic Goods Administration (TGA) notes that these changes are still to be confirmed by the European Parliament, and at this stage anticipates that the confirmation will occur in May 2022. Accordingly, any changes to the Australian principles is unlikely to be seen until at least 2024.
In addition to accommodating the present focus on COVID-19, the TGA has indicated that the delayed commencement will allow for further consultation with industry on guidance materials and implementation.
For advice in Australia, please contact Greg Bodulovic (Partner) and Stephanie Wang (Senior Associate).