Saudi Arabia’s Medical Device Interim Regulation (MDIR), which includes new documentation requirements for foreign manufacturers importing to the Saudi market, have gone into effect.
According to the Saudi Food & Drug Authority’s (SFDA) website as well as email communication from BSI, foreign medical device manufacturers must provide the regulator with documents proving that their products are authorized to be sold in one or more Global Harmonization Task Force founding members—Australia, Canada, Europe, Japan or the US. Devices must also provide documentation showing compliance with MDIR requirements, after which the SFDA will issue marketing authorizations allowing manufacturers to begin or continue selling their products in the country.
