How to find information related to international organizations and technical committees responsible for medical devices standards?
Answer
Through the link below:
https://www.sfda.gov.sa/ar/medicaldevices/about/administration/pre-market_scientific_evaluation/standards/Pages/international-organization.aspx
Question
How to know the differences between the Saudi standard and the international standard adopted with modification?
Answer
This can be done by looking through the "Modifcations Annex" which can be found in the Saudi standard's preview that shows the whole modifications done on the adopted international standard with modification.
Question
Is a preview of standard document availabe before buying it from the store?
Answer
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.
Question
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
