How to comment on drafts of guidelines and requirements?
Answer
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
Question
Where to find the complete list of Saudi's medical devices standards?
Answer
Through the link below:
https://sfda.gov.sa/ar/saudi_standards_lists?keys=&standards_title_eng=&standards_number=&page=0
Question
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
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
