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SFDA Fees for Medical Devices 
15Jan 2025
Blogs, Medical Device, SFDA, Trending Now admin Comments: 0

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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sfda classification
14Jan 2025
Blogs, Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

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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Saudi Authorized Representative
13Jan 2025
Medical Device, Blogs, SFDA admin Comments: 0

Saudi Authorized Representative for Medical Devices 

Medical device manufacturers aiming to enter the Saudi market must comply with the Saudi Food and Drug Authority (SFDA) regulations. For companies without a legal entity in the Kingdom of Saudi Arabia (KSA), appointing a Saudi Authorized Representative (Saudi AR) is a mandatory requirement. This post explores the responsibilities of a Saudi AR and the advantages of working with medical device regulatory consultants in Saudi Arabia.  Why Do You Need an Authorized Representative in Saudi Arabia?Â...
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register medical devices in the saudi market
10Jan 2025
Medical Device, Registrations, SFDA, Trending Now admin Comments: 0

How to Register Medical Devices in the Saudi Market?

Saudi Arabia is a growing hub for the medical device market, presenting tremendous opportunities for manufacturers worldwide. The Saudi Food and Drug Authority (SFDA) regulates the process, ensuring that only safe, high-quality devices enter the market. This guide simplifies the steps to help manufacturers navigate Saudi Arabia medical device registration process efficiently. Why is Saudi Arabia a Key Market for Medical Devices? Saudi Arabia is the largest and most populous country in the Gulf C...
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