Saudi Gazette report

PARIS — The International Committee for Medical Device Quality Standards in the International Organization for Standardization (ISO/TC 210) approved the proposal of Saudi Arabia to translate the international standards for managing 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. Saudi Arabia was represented by the Saudi Food and Drug Authority (SFDA) at the annual meeting of the organization in Paris.

A working team led by the Kingdom was formed to enhance the presence of the Arabic language in international standards legislation for ISO, taking into account the fact that the number of Arabic language speakers around the world stood at around 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, Saudi Arabia 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)