KSA
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs
Saudi Arabia
The article outlines the basics of the regulatory framework for innovative medical devices.
Saudi Arabia
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
Saudi Arabia
The article highlights the aspects related to the regulatory status of the changes related to medical devices allowed for marketing and use in the country. Table of Contents The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of...
Saudi Arabia
The article provides an overview of the regulatory requirements for clinical trials of medical devices. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulating authority in the sphere of healthcare products, has published...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the approach to be applied for bundling/grouping medical devices intended to be marketed and used in the...
