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
How to participate on writing and developing medical devices standards?
Answer
Yes, through participating in national technical committees or announcement for public comments. For more infromation please contact regulation and standards section through the Email: md.standards@sfda.gov.sa
Question
How to contact for inquiries about medical devices standards?
Answer
For more infromation please contact regulation and standards section through the Email: md.standards@sfda.gov.sa
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
"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 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
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 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 is In-Vitro Medical Device definition
Answer
In-Vitro Medical Device:
Means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles
