Medical devices Membership | Saudi Food and Drug Authority

Medical devices sector membership

Global Harmonization Working Party (GHWP)
International Organization for Standardization (ISO)
International Electrotechnical Commission (IEC)
Gulf Cooperation Council (GCC) Standardization Organization (GSO)
The Arab Industrial Development, Standardization and Mining Organization (AIDSMO)

Global Harmonization Working Party (GHWP)

Global Harmonization Working Party is an international scientific organization that aims to develop regulatory systems and legislations among member economics. It includes 32 regulatory bodies in addition to a number of independent consultants with regulatory expertise from the United States, Europe and Japan. The organization is continuing coordination with a number of strategic partners , other organizations such as (APEC, WHO, OECD) and the International Medical Devices Regulators Forum (IMDRF) aiming to establish harmonization and convergence platform for medical devices in accordance with international best practices, and helping emerging countries to build their regulatory framework .. GHWP is chaired by Eng. Ali Al-Dalaan, the Executive Vice President of the Medical Devices Sector since 2018. Eng. Ali has previously held leadership positions in the organization. He was the Co-chair of the scientific and technical work groups and head of the quality management working group from 2008 to 2014, and then Chair of scientific and technical work groups from 2014 to 2018.. During the Kingdom’s presidency of the organization since 2018, the member economics approved the proposal of the Kingdom of Saudi Arabia to change the name from Asian harmonization working party to global harmonization working party (GHWP) in order to achieve more harmonization and convergence with global countries and strengthen and develop the regulatory system for medical devices..Moreover, SFDA participates actively in all nine scientific and technical work groups and chairing two working groups (pre-marketing requirements - medical software, and the quality management system for medical devices: audit and evaluation)

International Organization for Standardization (ISO)

The Saudi Food and Drug Authority (SFDA) has been participating in the International Organization for Standardization (ISO) as a “participant” membership since 2013 in coordination with the Saudi Standards, Metrology and Quality Organization (SASO). The SFDA has been joined in (16) technical committees in the field of medical devices, these committees are, for example, rubber and rubber products (TC 45), biological and clinical evaluation of medical devices (TC 194), quality management and corresponding general aspects for medical devices (TC 210), health informatics (TC 215). Also, the SFDA, supervises on the national work teams corresponding to the international committees, which include in its membership representatives of the relevant authorities from the governmental and private sectors.

International Electrotechnical Commission (IEC)

The Saudi Food and Drug Authority (SFDA) has been participating an active member (Participant) in the International Electrotechnical Commission since 2014 in coordination with the Saudi Standards, Metrology and Quality Organization (SASO) in the International Technical Committee for Electrical Devices Used in Medical practice IEC/TC62, contains 4 sub-committees which are (common aspects of electrical equipment Used in medical practice (SC 62A), diagnostic imaging devices (SC 62B), radiotherapy, nuclear medicine and radiation dosimetry (SC 62C), other medical electrical devices (SC 62D).

Gulf Cooperation Council (GCC) Standardization Organization (GSO)

The Saudi Food and Drug Authority (SFDA) has been participating as an active member of the regional Standardization Organization for the Cooperation Council for the Arab States of the Gulf since 2012. The Standardization Organization aims to unify the various standardization activities and follow up their implementation and commitment to them in cooperation and coordination with the National Standardization Bodies in the member states, in a way that contributes to the development of their production and service sectors, the development of intra-trade, consumer protection, environment and public health, and the promotion of Gulf industries, products and services in order to support the Gulf economy, preserve the gains of member states, and contribute to reducing technical barriers to trade, in line with the objectives of the GCC Customs Union and the Gulf Common Market. The Kingdom of Saudi Arabia also holds the presidency and secretariat of the Gulf Technical Committee for Medical Devices and Supplies GSO/TC 11, as well as managing, organizing and participating in work programs.

The Arab Industrial Development, Standardization and Mining Organization (AIDSMO)

The Kingdom of Saudi Arabia, represented by The Saudi Food and Drug Authority (SFDA) - Medical Devices Sector, is the presidency and secretariat of the Arab Technical Committee for Standardization of Medical Devices and Supplies (AIDSMO/TC4) since 2020, which includes in its membership the Kingdom of Saudi Arabia, the Kingdom of Morocco, the Hashemite Kingdom of Jordan, the Arab Republic of Egypt and the State of Palestine The Kingdom of Bahrain, the State of Kuwait, the Lebanese Republic, the Republic of Yemen, and the Republic of Somalia. The Arab Technical Committee for Standardization of Medical Devices and Supplies is affiliated to the Standards and Metrology Center in the Arab Organization for Industrial Development, Standardization and Mining, which includes in its membership 21 Arab countries and it is an organization affiliated with the League of Arab States . The committee is one of the fifteen committees responsible for working to unify standards and specifications among Arab countries to remove technical barriers and obstacles that hinder trade exchange between them, work to raise the level of quality, develop plans and programs for standardization of the medical devices and supplies sector, and follow up their implementation until the issuance of unified Arab standards with harmonization of international standards.