Saudi Arabia Medical Device Regulations

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الأنظمة واللوائح | Saudi Food and Drug Authority - SFDA

https://www.sfda.gov.sa/en/regulations

Medical Devices Requirement Requirements for Clinical Trials of Medical Devices (MDS-REQ 2) 2022-11-17 Drugs List The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products Guideline 2022-11-15 …

KSA update: New Saudi medical device regulation, GHTF

https://www.emergobyul.com/news/ksa-update-new-saudi-medical-device-regulation-ghtf-applications-ai-requirements-and-more

A royal decree of the Kingdom of Saudi Arabia (KSA) established a new medical device regulation, to take effect later this year. The Saudi Food and Drug …

SFDA Medical Device Registration in Saudi …

https://pharmaknowl.com/sfda-medical-devices-registration-saudi-arabia/

Mar 11, 2021

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 have …

Medical Devices Interim Regulation - SFDA

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

KSA: means the Kingdom of Saudi Arabia SFDA: means Saudi Food and Drug Authority The Board: the SFDA board of directors Party: means any natural or legal person. …

Medical Devices Regulation Overview and Updates

http://ahwp.info/sites/default/files/Annex18_Saudi%20Arabia%20updates.pdf

To ensure safety, effectiveness and quality of medical devices and their performance according to their intended purpose and to ensure the safety of related electronic …

Saudi Arabia Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/saudi-arabia/

Before selling in Saudi Arabia, device must be authorized in reference country (Australia, Canada, Europe, Japan, or USA) Appoint representative in Saudi Arabia. …

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 and …

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

In December 2019, Saudi Arabia launched a new Unified Electronic System “GHAD” replacing existing medical devices systems for listing, registration and …

Regulatory, Pricing and Reimbursement Overview: Saudi …

https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-saudi-arabia/

Before being sold in the Kingdom of Saudi Arabia (KSA), medical devices must receive marketing authorization from the Saudi Food and Drug Authority (SFDA) …

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