Medical device registration in Saudi Arabia

Arabia Saudita
In Saudi Arabia, most devices require MDMA (Medical Device Marketing Authorization) authorization from the SFDA before placing a product on the market.
Registration in Saudi Arabia requires prior approval in one of the following reference markets: Australia, Canada, Europe, Japan or the United States.
Usually a classification of the medical device in the target market will determine the way SFDA will classify the device.
You must also appoint an authorized representative of Saudi Arabia if you do not have an office in Saudi Arabia. Your authorized representative must obtain an authorized representative license.
Maytal experts, together with their partners located in Saudi Arabi, can:
  • helps to prepare documents to be submitted to SFDA
  • manage the relationships with SFDA, during the review process
  • Supply local representation service, necessary for foreign manufacturers.