IMDRF
The new article addresses the aspects related to establishing efficient communication between medical device manufacturers and healthcare providers with respect to medical devices used and also provides definitions of the most important terms and concepts. Table Of...
FDA
The new article highlights the aspects related to specific tests to be conducted by medical device manufacturers in order to demonstrate compliance with the applicable regulatory requirements. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
Saudi Arabia
The new article highlights the key points related to the regulatory requirements associated with changes to the materials used in medical devices. Also, it outlines the scope of information to be included in the medical device change form to be submitted by the...
FDA
The new article addresses the aspects related to the Modification Protocol section, especially to its content in general and data management practices in particular. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Australia and Oceania
The article provides an overview of the existing regulatory framework for software-based medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in healthcare products, has published guidelines on the...
FDA
The article provides an overview of the regulatory requirements for certain types of medical devices in line with the 510(k) premarket notification pathway. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
