E Services


Description

The National Center For Medical Devices Reporting (NCMDR) is devoted to receive adverse events reports and feedback information about any medical devices malfunction from hospitals and healthcare facilities all around KSA, as well as, receiving product recalls from manufacturers and suppliers to insure that proper action had been conducted. To see guideline for Health Care Providers Please Click Here and guideline for Manufacturers ,Authorized representatives ,Importers & Distributers Please Click Here

Link

http://ncmdr.sfda.gov.sa/

تقييم جودة الخدمة المقدمة

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Description

MDNR is an enrollment scheme for medical devices establishments, manufacturers, agents and suppliers in Saudi Arabia. For more information on how to register in the system Please Click Here

Link

http://mdnr.sfda.gov.sa/MDNR/Public/Default.aspx

تقييم جودة الخدمة المقدمة

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Description

The Saudi Food and Drug Authority represented by the Medical devices sector in cooperation with emergency care research institute (ECRI) is very pleased to offer to the Saudi hospitals both public and private six highly specialized databases that contain valuable information related to medical devices.

Link

http://www.sfda.gov.sa/en/medicaldevices/eservices/Pages/MedicalDevicesDB.aspx

تقييم جودة الخدمة المقدمة

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Description

Medical device establishment licensing system (MDELS) enables the Establishments to submit their applications medical device establishment license electronically. For more information on how to register in the system Please Click Here

Link

https://mdel.sfda.gov.sa/

تقييم جودة الخدمة المقدمة

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Description

Medical Devices Importing License System "MDIL" is a Licensing system for the establishments involved in the importation of medical devices in Saudi Arabia. It is a web based system where all applications for importation of Medical IVD’s, Non-Medical IVD’s, Distillations, Chemicals and Gases shall be applied online. The Importing License shall be obtained prior to shipment.

Link

http://mdil.sfda.gov.sa/MDIL/

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Description

The Medical Device Marketing Authorisation (MDMA) system allows authorised representatives and local manufacturers to submit applications electronically for marketing authorisation that permits the relevant medical devices to be placed on the market of the KSA. For more information on how to register in the system Please

- MDMA User Manual

- Guidance for on-line application form (USA)

- Guidance for on-line application form (European )​

Link

http://mdma.sfda.gov.sa/

تقييم جودة الخدمة المقدمة

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Description

MDC SYSTEM is an online classification system to help the applicant in classification of the product whether it’s fall under medical device responsibilities or not.

 

Link

http://mdc.sfda.gov.sa/Default.En.aspx

تقييم جودة الخدمة المقدمة

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