SFDA Participates in Annual International Meeting of ISO's Quality Management System Standards Committee for Medical Devices and Supplies

<p>The Saudi Food and Drug Authority (SFDA) has participated in the 24th Annual Meeting of the International Technical Committee for the Specifications of the Quality Management System for Medical Devices and Supplies of the International Organization for Standardization (ISO), which was held in Arlington, USA, in the presence of representatives from 25 countries. </p>

<p>In the meetings of the sub-working groups of the Technical Committee, the committee discussed many prominent issues in the field of quality and risks for medical devices, and the importance of working on technical specifications that support the medical device industry to meet technical development in artificial intelligence, software and digital health, and there are regulatory solutions to meet these challenges. </p>

<p>The committee was briefed on the Kingdom's experience and developments in the quality management system for medical devices and supplies, and the methodology of application to factories and facilities to achieve safety and performance requirements in accordance with the medical devices and supplies system issued by Royal Decree M/54. The committee requested that the Kingdom join the working group concerned with reviewing and developing the quality management system guide to include applications of artificial intelligence, modern technologies, and others. </p>

<p>This participation comes to enhance the SFDA's role in international organizations, as the Kingdom, represented by the SFDA, is a key member of 16 international technical committees for medical device specifications in the International Organization for Standardization (ISO) and the International Electrotechnical Organization (IEC), and annually participates in more than 500 projects for international specifications in several fields of medical devices.</p>