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

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.

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

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