Saudi Arabia

1/3/2023

MDS – G010 Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices The purpose of this guidance is to clarify the requirements for obtaining Medical Devices Marketing Authorization (MDMA) for Artificial Intelligence (AI) and Machine Learning (ML) based medical devices to place them on the market within KSA.

3/23/2023

MDS-REQ 11 Requirements for Post-Market Surveillance of Medical Devices. " The purpose of this document is to specify and clarify the requirements for post-market surveillance of medical devices, including the procedures and activities. “Translated Version”"

3/22/2023

MDS – G012 Guidance on MDMA – Significant and Non-Significant Changes The purpose of this document is to clarify the requirements, with examples, of reporting or notifying the SFDA of significant and non-significant changes to marketing authorized medical devices/supplies. And this document applies to change(s) made to medical devices (including IVDs) held by MDMA.

12/13/2022

MDS – G008 Guidance on Medical Devices Classification The purpose of this guidance is to help medical device manufacturers to classify their devices in KSA correctly.

12/13/2022

MDS – REQ 10 Requirements for Inspections and Quality Management System for Medical Devices The purpose of this document is to specify and clarify the requirements for inspection and Quality Management Systems for establishments and medical devices. "Translated version"

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