register

News & Trends - MedTech & Diagnostics

Delays to medical device regulatory changes and reforms

Health Industry Hub | June 22, 2020 |

MedTech News: Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focused on the COVID-19 crisis, the Australian Government intends asking the Governor-General in Council to agree to the proposed delay of the commencement of a number of medical device reforms.

The delay would also support additional time for the Therapeutic Goods Administration (the TGA) to consult with the medical device industry and health care professionals on guidance material relating to the reforms.

The Australian Medical Device Regulations would be amended to delay implementation of the reforms from 25 August 2020 to:

  • 25 November 2021 for reclassification of certain devices, including
    • spinal implantable medical devices
    • active implantable medical devices
    • medical devices that administer medicines or biologicals by inhalation
    • medical devices that are substances (or combinations of substances) for introduction into the body
    • active medical devices for therapy that include a diagnostic function to significantly determine patient management, and
    • medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system
  • 25 February 2021 for medical device software
  • 25 February 2021 for personalised medical devices (including 3D printed devices) and
  • 25 November 2021 for systems or procedure packs

Register-and-join-Health-Industry-Hub-Pharma-MedTech-Biotech

Further information about the reforms will continue to be published, with the TGA working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months.

Essential Principles

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 European Union Medical Device Regulation changes (i.e. May 2023) and IVD Medical Device Regulations – this is still to be confirmed by the European Parliament, but is likely to be May 2022, so two years after that date.

This would provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.

Selfcare In Healthcare Coalition on Mental Health Support in Pharma, Biotech and MedTech

News & Trends - Pharmaceuticals

Federal Health Minister succumbs to pressure, commits to extra meeting to clear PBAC backlog

Federal Health Minister succumbs to pressure, commits to extra meeting to clear PBAC backlog

Health Industry Hub | November 7, 2024 |

Pharma News: The Minister for Health and Aged Care, Mark Butler MP, has confirmed that the Pharmaceutical Benefits Advisory Committee […]

More


News & Trends - MedTech & Diagnostics

Medtech company partners with Aussie researchers in AI technology for GI cancer detection

Medtech company partners with Aussie researchers in AI technology for GI cancer detection

Health Industry Hub | November 7, 2024 |

MedTech & Diagnostics News: To develop a next-generation gastrointestinal (GI) flexible endomicroscope equipped with edge-artificial intelligence (AI) technology, Monash University’s […]

More


News & Trends - Pharmaceuticals

Local oncologists first to enrol prostate cancer patients in phase 3 theranostics trial

Local oncologists first to enrol prostate cancer patients in phase 3 theranostics trial

Health Industry Hub | November 7, 2024 |

Pharma News: GenesisCare oncologists have achieved a significant milestone, becoming the first to enrol and deliver patient treatment in a […]

More


Human Resources

Ipsen's culture of 'collaboration and diversity' earns Great Place to Work certification

Ipsen’s culture of ‘collaboration and diversity’ earns Great Place to Work certification

Health Industry Hub | November 6, 2024 |

Ipsen Australia and New Zealand has announced its certification as a Great Place to Work in 2024, joining 11 other […]

More


This content is copyright protected. Please subscribe to gain access.