FAQ
FAQ
Is a preview of standard document availabe before buying it from the store?
Yes. This can be done by clicking on "Preview" button that is founded next to the standard's subject, where the standard's foreword, scope and other information will appear.
What is the most important parts in a standard document?
Standards document contains many importants parts such as scope, normative references, terms and definitions, general requierments, marking, labelling and packaging and many more depend on the standard subject.
When does consider software program or electronic application as a medical device?
It consider a medical device if its intended use meets any of the purpose(s) mentioned in the medical device definition, whether used separately or as part of a medical device.
How you can transfer MDMA from previous AR to a new one
Through GHAD System- Go to eligible services- product services – Marketing Authorization - transfer MDMA
How can i obtain marketing authorization of in vitro diagnostic device?
You can obtain marketing authorization of in vitro diagnostic device in the same procedures of obtaining marketing authorization of medical product.
What are the fees of marketing authorization application and how long does it take to issue?
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.
"how can I check if a product has marketing permission or not? "
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).
"How medical devices classification must be performed"
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
What is Unique Device Identification (UDI) for Medical Devices?
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/