Regstration in Saudi Arabia
Access to the Saudi market
In Saudi Arabia, most devices require a Medical Device Marketing Authorization (MDMA) from the SFDA before market entry.
In recent years, MDMA has increased registration requirements, requesting a full technical dossier, with more detailed documentation for higher-risk products.
Foreign manufacturers must also appoint an Authorized Representative in Saudi Arabia if they do not have a local entity. The Authorized Representative must obtain a representative license.
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