MHRA
The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products,...
MHRA
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
MHRA
The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority,...
MHRA
The new article highlights the aspects related to conformity assessment of In- Vitro Diagnostic medical devices. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has...
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
