Translation of international standards for managing the quality system of medical devices and management of risks of medical devices into the Arabic language approved

The International Committee for Medical Device Quality Standards within the International Organisation for Standardisation (ISO/TC 210) has authorised Saudi Arabia's proposal to translate the international standards into Arabic for managing the medical device quality system (ISO 13485:2016) and the medical device risk management (ISO 14791:2019). The Saudi Food and Drug Authority (SFDA) represented Saudi Arabia at the organization's annual conference in Paris.

Given that there were over 464 million Arabic speakers worldwide, a working group headed by the Kingdom was established to increase the Arabic language's representation in ISO international standards law. These standards help to ensure the safety and calibre of medical devices by defining quality controls and risk management at every stage of the device's lifespan.

The development is a continuation of the Kingdom's leadership in supporting and elevating the standing of Arabic, which is a result of the Kingdom's significant influence in regional and global standardisation organisations. Saudi Arabia is currently the chair of the Arab Industrial Development Standardisation and Mining Organization's (AIDSMO) Technical Committee for Medical Device Standards. It also actively participates in international standardisation committees, offering technical advice and spearheading the creation of new standard specification projects for medical devices. The Saudi Standards, Metrology, and Quality Organisation (SASO) is consulted in this process.