Saudi Arabia
The article provides a general overview of the regulatory approach to be applied concerning biotechnology-based medical devices intended to be marketed and used in Saudi Arabia.
Saudi Arabia
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
Saudi Arabia
The article provides a general overview of the classification framework for medical devices.
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...
