Saudi Arabia Medical Device

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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 Authority (SFDA) also extended the period during which GHTF registration applications would be accepted, published a guidance document on medical software utilizing artificial intelligence (AI) or big data, and updated the master classification guidance.

SFDA - Medical Device Marketing Authorisation System

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

Establish an overall profile of the medical devices presently on the Kingdom of Saudi Arabia (KSA) market. Develop, adopt and apply a Medical Devices Interim Regulation, …

الأنظمة واللوائح | Saudi Food and Drug Authority - SFDA

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

All The Authority Food Drugs Medical Devices Feed Tobacco Pesticides Laboratories Cosmetics Halal Nutrition Regulations Exceptions List Click Here 2022-12 …

Saudi Arabia Medical Devices Market: Outlook and …

https://www.iqvia.com/locations/middle-east-and-africa/library/white-papers/saudi-arabia-medical-devices-market

Saudi Arabia Medical Devices Market: Outlook and Potential Prospects Thank you for your interest. Please complete this form to download. The global medical …

Saudi Arabia Medical Devices Market is the biggest in …

https://www.globenewswire.com/en/news-release/2022/08/05/2493001/0/en/Saudi-Arabia-Medical-Devices-Market-is-the-biggest-in-the-MENA-region-with-stable-demand-growing-at-a-single-digit-CAGR-during-2016-2021-Ken-Research.html

By Type of Cardiac Device Angioplasty Device Cardiac Rhythm Management ICD Implants Pacemakers Heart-Lung Machines Others By Type of Respiratory Products …

SFDA Medical Device Registration in Saudi …

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

We can summarize the registration process for a medical device in Saudi Arabia in the following few steps: Identify the SFDA medical device classification. …

Medical Equipment List | Saudi Food and Drug Authority

https://www.sfda.gov.sa/en/medical-equipment-list

Medical Device Listing Number : Device Type : Product Description : Category: Classification: gmdn : Authorized Representative : Expiry Date: Manufacturer Device …

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 been …

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 …

Saudi Arabia Medical Device Regulations | RegDesk

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

Medical Device Definition. "Medical device" means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other …

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