Through GHAD System- Go to eligible services- product services – Marketing Authorization - transfer MDMA
You can obtain marketing authorization of in vitro diagnostic device in the same procedures of obtaining marketing authorization of medical product.
You can reach to fees of marketing authorization application via:
https://sfda.gov.sa/sites/default/files/2019-10/Fees-Rev-Times-Mark-Aut-App-ar%2Cen_9.pdf
the marketing authorization will be issued during 35 business days as maximum if all requirements are fulfilled.
You can check if the medical product has already obtained marketing permission via:
https://sfda.gov.sa/ar/medical-equipment-list
or
You can send an inquiry about the product to the following email: md.rs@sfda.gov.sa
including (manufacturer name, brand name, model).
The manufacturer is responsible for determining a device's classification using SFDA classification rules. The manufacturer needs to consider all applicable rules and classify the device based on the highest risk class. Additionally, the manufacturer must justify the chosen class/rule for both the device and any accessories.
You can reach the Guidance on Medical Devices Classification via:
https://sfda.gov.sa/sites/default/files/2020-03/MDS%E2%80%93G42.pdf
The UDI intends to unambiguously identify any medical device based on a globally accepted identification and coding standard that is accredited by regulatory bodies such as GS1, ICCBBA, HIBCC.
You can visit Unique Device Identification (SAUDI-DI) system and viewing the frequently asked questions about the system through:
https://udi.sfda.gov.sa/
Yes, it is allowed if they are made for the main medical device
The payment fee of MDMA must be done during 30 calendar days
You can find guidance MDS-40 on:
https://sfda.gov.sa/sites/default/files/2020-03/MDS-G40en.pdf