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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Jun 12, 2023
Saudi Arabia
The new article highlights the aspects related to the changes to the design of a medical device and the potential impact thereof. Table of Contents The Saudi Food and Drug Administration (SFDA), a county’s regulatory agency in the sphere of healthcare products, has...
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May 24, 2023
FDA
The new article addresses the aspects related to the content of a monitoring plan, as well as the follow-up procedures and the way they should be documented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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