May 25, 2021
Australia and Oceania
The Therapeutic Goods Administration(TGA), the Australian regulating authority in the sphere of medical devices, has published guidance describing specific aspects related to the Declaration of Conformity for certain low-risk medical devices. In particular, the scope...
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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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May 14, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulations, has published an official notice on the reclassification of certain medical devices. According to the document, the TGA intends to review the existing...
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Apr 19, 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 guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal...
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