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Saudi AR License Renewal Fees Process
16Apr 2025
Blogs, Authorised Representatives, Medical Device, Saudi Arabia, SFDA, Trending Now admin

Saudi AR License Renewal Fees & Process for Medical Devices

Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring timely renewal of the Authorized Representative (AR) license along with understanding the applicable SFDA fee for medical device representation. This guide outlines the SFDA AR license renewal process, the applicable fees, and important timelines to help manufacturers and their representative...
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UAE Medical Device Registration Process
14Apr 2025
Blogs, Medical Device, Registrations, Trending Now admin

Medical Device Registration in UAE

UAE Medical Device Registration: A Step-by-Step Guide The UAE’s healthcare sector has grown significantly in recent years, leading to an increased demand for medical devices. To ensure patient safety, regulatory authorities in the UAE have laid down strict guidelines for registering medical devices. This process helps ensure that medical devices sold in the UAE are safe, effective, and high-quality. Whether you are a manufacturer or an importer, understanding the UAE medical device registr...
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register medical devices in the saudi market
11Apr 2025
Medical Device, Registrations, SFDA, Trending Now admin

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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Clinical Evaluation vs Clinical Study
10Apr 2025
Blogs, Regulations, Trending Now admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinction between the two is crucial for manufacturers aiming to obtain and maintain regulatory approval in key markets like the EU and UK. This article breaks down the difference between clinical study and clinical evaluation, and explains when and why each is required.  What is a Clinical Evaluation? A clinical evalua...
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What is medical translations
08Apr 2025
Blogs, Translations, Trending Now admin

What Is Medical Translation and Why Is It Critical? 

When it comes to healthcare, there’s no room for miscommunication. Whether it’s medical research, pharmaceutical products, clinical trials, or regulatory documentation, information often needs to cross linguistic and cultural lines. That’s where medical translation comes in — a highly specialized field that plays a crucial role in delivering safe and effective healthcare worldwide.  What is Medical Translation? Medical translation refers to the process of accurately converting m...
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Medical Device Lifecycle Management
25Mar 2025
News, General Information, Trending Now admin

Why Lifecycle Management Matters for Medical Devices? 

The medical device industry operates in a highly regulated environment where safety, efficacy, and compliance are critical. To ensure devices remain safe and effective throughout their lifespan, manufacturers must adopt a robust lifecycle management approach. This article explores why lifecycle management matters for medical devices and how it benefits manufacturers, healthcare providers, and patients.  Understanding Medical Device Lifecycle Management  Medical device lifecycle management...
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Import License for Medical Devices in India
24Mar 2025
Blogs, CDSCO, India, Trending Now admin

Import License for Medical Devices in India 

India’s medical device industry is growing rapidly, with both domestic manufacturing and international imports driving the sector forward. However, importing medical devices into India requires compliance with strict regulatory frameworks governed by the Central Drugs Standard Control Organization (CDSCO). One of the critical steps in this process is obtaining a Medical Device Import License India. Let’s walk through what this means, why it’s important, and how forms like Form MD-14 and Fo...
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Quality Assurance for Medical Equipment in UAE
19Mar 2025
UAE, Blogs, Trending Now admin

Quality Assurance for Medical Equipment in the UAE 

The UAE has become a healthcare hub in the Middle East, with hospitals and clinics adopting advanced medical technologies. To maintain the highest standards in patient care, medical equipment quality assurance in UAE is a crucial focus area, ensuring that all devices used in clinical settings are safe, reliable, and effective.  The Importance of Medical Device Quality Assurance  Medical device quality assurances in UAE ensure that equipment used across healthcare institutions complies...
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What is PIF in UAE
18Mar 2025
Blogs, Trending Now, UAE admin

What is a Product Information File (PIF) in UAE ? 

Bringing pharmaceutical products to market in the UAE requires more than just quality manufacturing — it demands strict compliance with local regulatory requirements. One of the essential components in this process is the Product Information File (PIF), a detailed dossier that provides regulators with key information about a product’s composition, safety, efficacy, and more.  While commonly associated with cosmetics, the PIF is also critical for pharmaceuticals in the UAE and serves as a ce...
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Saudi Arabia’s SaMD regulations
13Mar 2025
Blogs, Saudi Arabia, Trending Now admin

How Saudi Arabia Regulates Software as a Medical Device (SaMD)? 

In recent years, Saudi Arabia has recognized the pivotal role of digital health solutions in modern healthcare. Central to this digital transformation is the regulation of Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) has established comprehensive guidelines, such as MDS-G23  Guidance on Software as a Medical Device, to ensure that SaMD products meet stringent safety and efficacy standards before entering the Saudi market.  Understanding SaMD  Softw...
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