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 article provides an overview of the regulatory framework for sample collection.
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 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...