Any material from which ionizing radiation is emitted, whether alone or within other equipment, classified as subject to the control of the SFDA. Including, naturally occurring radioactive materials.
Question
Is it possible to import used medical devices?
Answer
importation of used medical devices is not allowed
Question
Is the document (Declaration of conformity) for clearance the same as the document for registration?
Answer
The clearance document differs from the “declaration of conformity of the shipment to the control regulation for medical devices and products” and a document that mentions the information of registration and licensing of the products in the shipment and the manufacturer’s acknowledgment that the products were shipped by the importer
Question
How to comment on standards for national adoption?
Answer
Opinion Stage "https://ideasbank.sfda.gov.sa" provieds a space for experts and public to participate and commentts ongoing drafts?
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
Is the approval of SFDA required to conduct a clinical study on a medical device ?
Answer
SFDA represented by the medical devices sector requires obtaining prior approval before conducting any clinical study in accordance with the requirements mentioned in the 'Guideline for the Requirements of Clinical Studies for Medical Devices and Products (MDS - G20) and in compliance with the International Standard (ISO 14155) Concerning Good Clinical Practice.
The guidelines of the requirements for conducting clinical studies on medical devices can be referred to through the following links on the SFDA website:
- النسخة العربية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20a.pdfG20)ar.pdf
- النسخة الإنجليزية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20e_0.pdf
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 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
