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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May 24, 2023
Europe
The new article describes in detail special projects the authority intends to implement in order to introduce specific needs associated with the products based on innovative technologies. Table of Contents The Medicines and Healthcare Products Regulatory Agency...
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May 24, 2023
FDA
The new article addresses the aspects related to special factors to be considered when developing a monitoring plan, the way centralized monitoring should be implemented, and also emphasizes the importance of maintaining blinding to mitigate risks associated with...
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May 24, 2023
Europe
The new article addresses the matters related to the regulatory status of the products based on artificial intelligence technology, regulated as medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), a UK authority in the...
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