Saudi Medical Device Regulations

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الأنظمة واللوائح | Saudi Food and Drug Authority - SFDA

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

Regulations Exceptions List Click Here. 2022-12-26. 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 …

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 …

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

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 Device Registration and Approval in Saudi Arabia

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

Medical Device Regulations and Classification in Saudi Arabia REGULATORY AUTHORITY: Saudi Food and Drug Authority (SFDA) CLASSIFICATION …

KSA Update: New Guidance on Saudi Medical Device …

https://www.emergobyul.com/news/ksa-update-new-guidance-saudi-medical-device-classification-and-more

The SFDA has issued MDS-G008, Guidance on Medical Devices Classification, which replaces MDS-G42 and is based on the Medical Devices Law. The …

Medical Devices Interim Regulation - SFDA

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

To collect and maintain the information required for establishment registration and medical device listing under this Interim Regulation. To establish and maintain a profile of the …

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, ...

Saudi Arabia SFDA Guidance on UDI …

https://www.regdesk.co/sfda-udi/

Saudi Arabia SFDA Guidance on UDI Requirements Sep 17, 2020 The Saudi Food & Drug Authority (SFDA), the regulating authority in the sphere of …

Saudi Arabia: Having Your Medical Devices …

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 …

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