This document is an English translation of the SFDA guidelines (MDS-REQ 10) that is to define and clarify the requirements for the inspection and the quality management system for medical establishments, devices and supplies that are subject to the provisions of the system and the regulations and in accordance with what was stated in Article (33) of the executive regulations, which stipulates that “the SFDA is stipulated to issue inspection requirements and quality management system for medical devices and supplies; these requirements should include: the duties, powers, obligations, and rights of the inspector.“