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UAE Medical Device Registration Process
16Jan 2025
Blogs, Medical Device, Registrations, Trending Now admin Comments: 0

Guide to UAE Medical Device Registration Process 

Navigating the UAE medical device registration process is essential for manufacturers seeking access to the dynamic healthcare market of the United Arab Emirates. This guide outlines the steps and highlights the role of medical device regulatory consultants in the UAE to ensure compliance with UAE medical device regulations.  The UAE Ministry of Health and Prevention (MOHAP) regulates healthcare facilities, licenses professionals, and approves medications and medical devices. The UAE Minist...
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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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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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Cosmetic Regulations in Saudi Arabia
19Jun 2024
News, Cosmetics, SFDA, Trending Now admin Comments: 0

Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia

In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality. Legal Framework for Cosmetic Regulations in Saudi Arabia Saudi Arabia has es...
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05Feb 2024
News, Trending Now Cubicdesignz Comments: 0

Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process

TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA).  Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...
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