What is the most important parts in a standard document?
Answer
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.
Question
When does consider software program or electronic application as a medical device?
Answer
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.
Question
How you can transfer MDMA from previous AR to a new one
Answer
Through GHAD System- Go to eligible services- product services – Marketing Authorization - transfer MDMA
Question
How can i obtain marketing authorization of in vitro diagnostic device?
Answer
You can obtain marketing authorization of in vitro diagnostic device in the same procedures of obtaining marketing authorization of medical product.
Question
What are the fees of marketing authorization application and how long does it take to issue?
Answer
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.
Question
"how can I check if a product has marketing permission or not? "
Answer
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).
Question
"How medical devices classification must be performed"
Answer
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
Question
What is Unique Device Identification (UDI) for Medical Devices?
Answer
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/
Question
If there are many deferent types of accessories related to the medical device, is it allowed to register them in one application?
Answer
Yes, it is allowed if they are made for the main medical device
Question
What is the deadline to do the payment fee of medical device marketing authorization (MDMA) when it is requested from Saudi Food and Drug authority?
Answer
The payment fee of MDMA must be done during 30 calendar days
