The article provides a brief overview of the way medical devices should be registered when placed on the UK market. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has...
The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom. Table of Contents The...
The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices. Table of Contents The Medicines & Healthcare Products Regulatory Agency (MHRA),...
The article describes in detail the regulatory approach to be applied with respect to contact lenses allowed for marketing and use in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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...