SFDA Guidance on Biotechnology-Based Medical Devices: Overview
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.
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.
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
The article provides a general overview of the classification framework for medical devices.
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...
The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses. Table of Contents The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare...
The document highlights the key points associated with the licensing requirements for medical device establishments. Table of Contents The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a...
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