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TGA published review of safety and performance issues in Medical Device software

July 29, 2020 | |

Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

July 22, 2020 | |

Harmonised Standards for MDR? CEN/CENELEC say “Non”

July 2, 2020 | |

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

July 1, 2020 | |

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

June 19, 2020 | |

Proposed delayed commencement of certain Medical Device Regulatory Changes

June 12, 2020 | |

Software as a Medical Device – Upcoming Changes to the Australian Regulations

May 29, 2020 | |

Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods

May 19, 2020 | |

Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform

May 18, 2020 | |

Notified Body Updates for MDD, MDRs, IVDD and IVDR

May 4, 2020 | |
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