Jun 12, 2023
Europe
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...
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Jun 12, 2023
Europe
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),...
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Jun 12, 2023
FDA
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...
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Jun 12, 2023
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...
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Jun 12, 2023
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...
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