Australia: Understanding TGA's New Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal-Origin Substances – April/May 2025

• 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

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