What are the required documents that need to be submitted to obtain the medical devices Marketing Authorization Certificate through the Technical File assessment (TFA) track?
Answer
For information about the technical documentation required to obtain TFA Marketing Permissions , please refer to MDS-G5- Guidance on Requirements for Medical Device Listing and Marketing Authorization:
https://sfda.gov.sa/sites/default/files/2020-09/MDS-G5.pdf
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
Question
How can I communicate and inquire about clinical trial of medical device?
Answer
By contacting the clinical trial of medical device section via email: mdci @sfda.gov.sa
Question
What are the clinical trials of medical devices regulated by the SFDA?
Answer
Includes clinical trials aimed to evaluate the safety or effectiveness of a medical device
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
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
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
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.
