
Jan 27, 2023
Saudi Arabia
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
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Jan 27, 2023
FDA
The article provides an overview of the factors resulting in delaying or refusing an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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Jan 27, 2023
Australia and Oceania
The new article describes in detail the approach to be applied by the parties responsible for medical devices when notifying the authority about the products subject to reclassification they are going to supply. Table of Contents The Therapeutic Goods Administration...
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Jan 27, 2023
FDA
The new article highlights the aspects related to limitations the authority may impose with respect to the application of the program for certain medical devices or scenarios. Table of Contents The Food and Drug Administration (FDA or the Agency), the US authority in...
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Jan 27, 2023
Asia
The new article highlights the aspects related to the form and manner of reporting, responsible parties, as well as procedures and activities associated with reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the...
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Jan 27, 2023
Australia and Oceania
The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...
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