The document describes in detail the aspects to be taken into account when preparing a site master file. Table of Contents Introduction The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance...
The new article describes in detail the regulatory policy 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...
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...
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...
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...