SFDA Leads Project to Translate International Standards for Quality Systems and Medical Device Risks into Arabic

General News

2024-11-05

Riyadh, SPA: The International Committee for Medical Device Quality Standards in the International Organization for Standardization (ISO TC 210) approved the proposal of the Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA), to translate the international standards for the management of the quality system of medical devices (ISO 13485:2016) and the management of the risks of medical devices (ISO 14791:2019) into the Arabic language.This occurred during its annual meeting held in the French capital, Paris.A working team led by the Kingdom was formed to enhance the presence of the Arabic language in international standards legislation for ISO, given that the number of Arabic speakers is approximately 464 million.These standards specify quality controls and risk management throughout all stages of the entire lifecycle of the medical device, contributing to ensuring the safety and quality of medical devices.The development comes as an extension of the Kingdom's leadership in serving and enhancing the status of the Arabic language, stemming from the impactful role of the Kingdom in regional and international standardization organizations.Currently, the Kingdom chairs the Technical Committee for Medical Device Standards in the Arab Industrial Development Standardization and Mining Organization (AIDSMO) and actively participates in international standardization committees, providing technical opinions, leading, and developing new standard specification projects for medical devices.This is done in coordination with the Saudi Standards, Metrology, and Quality Organization (SASO).