Medical Devices National Registry Saudi Arabia

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.::MDNR:. - SFDA

https://mdnr.sfda.gov.sa/

The SFDA is pleased to launch the Medical Devices National Registry (MDNR) to list all Medical Devices Establishments, manufacturers, agents and suppliers dealing with …

SFDA - Medical Device Marketing Authorisation System

https://mdma.sfda.gov.sa/

Develop, adopt and apply a Medical Devices Interim Regulation, complemented by Implementing Rules, thereby ensuring legal certainty that only medical devices that …

Developing a Policy and Procedure Framework and …

https://pubmed.ncbi.nlm.nih.gov/29968641/

Developing a Policy and Procedure Framework and Manual for a National Comprehensive Implantable Medical Device Registry in Saudi Arabia Developing a Policy and …

Medical Device Registration and Approval in Saudi Arabia

https://arazygroup.com/medical-device-registration-saudi-arabia/

Medical Device Registration and Approval in Saudi Arabia General country-specific regulatory information is provided on this page for medical device registration …

SFDA medical device registration in Saudi Arabia - Emergo

https://www.emergobyul.com/services/medical-device-registration-and-approval-saudi-arabia

Establishing a National Medical Device Registry in Saudi …

https://pubmed.ncbi.nlm.nih.gov/26152943/

Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end …

New regulations for the Saudi Medtech Market - s-ge.com

https://www.s-ge.com/en/article/news/20211-c3-saudi-arabia-new-medtech-regulation

The Saudi Food & Drug Authority (SFDA), the medical device market regulator, plans to raise registration fees as well as implement a new device regulatory …

Saudi Arabia: Having Your Medical …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/saudi-arabia-is-it-worth-having-your-medical-devices-authorized/

2. Registration of medical devices in Saudi Arabia 2.1. Saudi Food and Drug Administration. Medical devices can only be placed on the market in Saudi Arabia if they have been registered with the SFDA …

Medical Devices Interim Regulation - SFDA

https://sfda.gov.sa/sites/default/files/2019-10/MD-InterimRegulation-en_0.pdf

Chapter Three Medical Devices National Registry (MDNR) Eight The SFDA shall institute and maintain a web-based Medical Devices National Registry (MDNR) that shall …

MDS-IR2 Implementing Rule on Establishment …

https://sfda.gov.sa/sites/default/files/2019-10/%28MDS%E2%80%93IR2%29en.pdf

the KSA involved in the manufacture and/or supply of medical devices to the KSA market, with the Medical Device National Registry. Article Three: Definitions The following …

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