Mar 6, 2024
Australia
The new article describes some aspects related to the information accompanying the products.
It provides additional clarifications regarding the parties’ obligations as set forth under the existing legal framework.
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Feb 2, 2023
Australia and Oceania
The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...
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May 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published guidance on reclassification of medical devices that administer medicines or biologicals by inhalation. The document falls within the...
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May 17, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, has published detailed guidance describing the documentation to be submitted by the applicant in the context of inclusion of a medical device to the...
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Apr 21, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published revised guidelines on clinical evidence for medical devices. The document is intended to provide medical...
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