News and Articles

Vaccine and Vial

Provisionally yours

January 27, 2021 | |
Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

January 22, 2021 | |

EUDAMED is LIVE

December 15, 2020 | |

MD Regulatory transition under Brexit

December 15, 2020 | |
Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

November 26, 2020 | |

Formulated ingredients and premixes: Keeping the IP of a PI

November 24, 2020 | |
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

November 19, 2020 | |
Taipei, Taiwan

Upcoming update to the Taiwan FDA Medical Devices Act

November 2, 2020 | |

TGA deploys Post Market Review Compliance Dashboard

October 29, 2020 | |
Time Lapse

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

October 19, 2020 | |
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