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
Жыл бұрын
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
11 ай бұрын
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
Жыл бұрын
Dear Maam, Is it possible to share the presentation file here. It would be very helpfull for us.
@regdeskrims
Жыл бұрын
Please provide your company email so that we can share the presentation slides with you. Thank you.
Пікірлер: 6