Welcome to Medical Regulations Gate
Medical Regulation GateMedical Regulation GateMedical Regulation Gate
(Sat - Thursday)
Kingdom of Saudi Arabia
Medical Regulation GateMedical Regulation GateMedical Regulation Gate

SFDA’s Quality Management System Auditing Organizations

Medical Regulations Gate - Importation Requirements of Medical Devices - Radioactive Materials - Particle Accelerators - Marketing Authorization Applications - Medical Masks and Particulate Respirators - Quality Management System - Products Classification Guidance - mdma registration - compliance timeframe for medical devices - Guidance on artificial intelligence - Medical ultraviolet radiation

SFDA has published a new implementing rule on how Quality Management Auditing Organizations can comply with SFDA’s requirements; Click here to read the official document.



Highlights from this Document

SFDA will perform (if needed) auditing for QMS of the establishment and overseas manufacturer

Any auditing organization applying for this designation, shall submit the required information mentioned in this article

SFDA’s role starts with reviewing the information submitted by the auditing organization, certify and audit whenever necessary

These articles mainly discuss the role and responsibilities of the Auditing Organization in terms of: Resources, Independence and Impartiality, Confidentiality and due professional care, Quality management procedures, Legal requirements and Liability Insurance

Listed here; are all the requirements to be provided upon applying for the designation to be an Auditing organization with SFDA.

This information applied to the personnel:

  • Conducting the application review
  • Reviewing audit reports
  • Auditors
  • Managing programs

For any questions, please drop us a message and we will contact you shortly