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...
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...
Saudi Arabia
The new article highlights the key points related to the specific categories of changes and describes the way the regulatory status of such changes should be determined based on the nature of such changes, the impact they are expected to have on the safety and...
Saudi Arabia
The new article describes in detail the way a risk-based approach should be applied with respect to clinical trials involving human subjects, paying special attention to the initial risk assessment to be carried out by the party responsible for a clinical...
Saudi Arabia
The new article highlights the aspects related to the requirements applicable to the entities providing medical maintenance services, and also the services in the sphere of technical consultation. Table of Contents The Saudi Food and Drug Administration (SFDA), a...
Saudi Arabia
The document highlights the aspects relate to the requirements for the entities providing testing services, as well as the services in the sphere of laboratory testing, and also the ones proving quality assurance and radiology measurement services. Table of Contents...
