FAQ
FAQ
What are the clinical trials of medical devices regulated by the SFDA?
Includes clinical trials aimed to evaluate the safety or effectiveness of a medical device
How to contact for inquiries about medical devices standards?
For more infromation please contact regulation and standards section through the Email: md.standards@sfda.gov.sa
How to participate on writing and developing medical devices standards?
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
Where to find the complete list of Saudi's medical devices standards?
Through the link below:
https://sfda.gov.sa/ar/saudi_standards_lists?keys=&standards_title_eng=&standards_number=&page=0
How to find information related to international organizations and technical committees responsible for medical devices standards?
Through the link below:
https://www.sfda.gov.sa/ar/medicaldevices/about/administration/pre-market_scientific_evaluation/standards/Pages/international-organization.aspx
How to know the differences between the Saudi standard and the international standard adopted with modification?
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.
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.