FDA
The new article addresses the aspects related to supplemental reports medical device manufacturers should submit and also provides an overview of the summary reporting instructions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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...
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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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...
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...
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...
