FAQ
FAQ
what does ,ean innovative medical device
A medical device may be designated as an Innovative Medical Device if it has an innovative feature in the technology, indications of use, or performance specifications that have no equivalence in the market. Furthermore, it is in the best interest of the patients, and at least one of the following criteria is met:
• the device provides considerable clinical advantages over an existing SFDA approved technology; OR
• the device provides considerable clinical advantages over an existing approved alternative treatment; OR
• there are no SFDA approved alternative technologies nor treatments available to patients
what is In-Vitro Medical Device definition
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
How can I communicate and inquire about clinical trial of medical device?
By contacting the clinical trial of medical device section via email: mdci @sfda.gov.sa
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.