Saudi Arabia Regulations Medical Devices

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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 …

Overview Medical | Saudi Food and Drug Authority - SFDA

https://sfda.gov.sa/en/overview-medical

Medical Devices Sector at Saudi Food and Drug Authority plays a pivotal role ensuring safety, efficacy and performance of medical devices under a comprehensive legislation …

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-G007, Guidelines for the Operation and Use of Radiation-Emitting Medical Devices, (link in Arabic) which provides guidelines for …

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. …

Saudi Arabia: Having Your Medical Devices Authorized?

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 (Saudi Food …

Pharmaceutical & medical device advertising regulation …

https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/saudi-arabia

Medical Devices Interim Regulations (“Interim Regulations”) 1 Issued by Saudi Food and Drug Authority Board of Directors Decree Number (1-8-1429) and dated 27 December …

New regulations for the Saudi Medtech Market

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 …

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 …

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