About this document
Clinical Investigation Guidelines for MDS-G5 by Elena Gutiérrez Campo is a document available to read on EtoBox.
This document provides guidance on conducting clinical investigations (trials) of medical devices within Saudi Arabia. It outlines the requirements, required documents, and reporting procedures. Key points include that clinical investigations must be approved by SFDA and the ethics committee before starting. Sponsors must submit application documents, progress reports, and notifications of changes, adverse events or early termination. The guidance aims to clarify the regulatory process for conducting medica
- Author
- Elena Gutiérrez Campo
- Language
- EN