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SFDA

SFDA Fees for Medical Devices 

Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
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Understanding SFDA Classifications: A Key Step for Saudi Medical Device Registration 

The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating medical devices in Saudi Arabia. For manufacturers aiming for successful Saudi medical device registration, understanding and adhering to the SFDA classification system is crucial. In this blog, we break down the SFDA’s medical device classification framework, ensuring compliance with Saudi Arabia medical device regulations.  What are SFDA Medical Device Classifications?  The SFDA classification system ca...
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Unlocking Opportunities: Understanding Saudi Arabia Medical Device Approval

Saudi Arabia Medical Device Approval The Saudi Arabian Medical device registration and Saudi Arabia medical device approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA). SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on th...
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