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...
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...
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...
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...
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...