FDA
The article provides an overview of the regulatory approach to be applied with respect to certain medical devices used in the context of the pandemic. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Saudi Arabia
The new article highlights the aspects related to the requirements for the entities involved in conformity assessment and verification of clinical trials. Table of Contents The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of...
FDA
The new article pays special attention to the situations when reports of assembly are not required and also provides additional recommendations regarding their content. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Asia
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
Saudi Arabia
The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare...
FDA
The new article provides additional clarifications regarding the aspects related to specific cases when assembly reports are required or not required Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
