Canada
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects related to the medical device establishment license (MDEL), special permission necessary to carry out the...
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...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a final guidance document dedicated to the submission of 510(k) notifications for changes to medical devices that have already been...
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...
Canada
Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In...
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