Saudi Arabia - Deep Dive Into Medical Devices Classifications And Registrations Procedure

Great insights into the Saudi Arabian classification system and key regulatory considerations when registering medical devices in Saudi Arabia.
Our Regulatory Intelligence Associate, Baraa Nofal has covered the following topics:
👉 What are the rules that classify the risk of medical devices?
👉What risks are associated with medical device production if they do not comply with SFDA requirements?
👉 What process do producers need to go through the medical devices registration?
👉 What happens once you need to update your approved license?

[@nakfurtulubka14]

Thank you for the informative presentation. Could you answer me, how european manufacturere handle the current situation with the proposal of the MDR. As you know there a two ways. The Notified Body should write a Confirmation letter for the manufacturer or themanufacture must write a own statement. But the Notified Bodies are currently not ready beacuse they must implement this proposal in their own process. This takes time. But if the manufacturer has no CE Certification acc. MDR and the valid MDD Certification will expired in the next time, how could manufacturer extend the registration in Saudi without the Confirmation Letter?. Accept SFDA/KSA self-written statements? Thank you.

[@nusrathbaig6902]

Thank you for having an informative presentation. I would like to learn how in ghad system we can choose TFA route. Is it same as MDMA selection then which jurisdiction we have to choose if no ghtf route

[@baraanofal1640]

In Ghad system the MDMA it is same as TFA that incudes the new regulation to include the technical file, I just say TFA to refer for the technical file documentation, MDMA: mean Marketing Authorization of Medical Devices in Saudi Arabia. So in the Ghad portal you will chose MDMA to apply for your application and completing your file.

[@Abinradh]

Dear Maam, Is it possible to share the presentation file here. It would be very helpfull for us.

[@regdeskrims]

Please provide your company email so that we can share the presentation slides with you. Thank you.