Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a detailed guidance document dedicated to the process of inclusion of medical devices in the Australian Therapeutic Goods Register, the...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how...
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