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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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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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Saudi Arabia’s SFDA Issues New ISO 13485 Guidance for Medical Devices
07Apr 2025
News, Blogs, Saudi Arabia, SFDA admin

Saudi Arabia’s SFDA Issues New ISO 13485 Guidance for Medical Devices

The Saudi Food & Drug Authority (SFDA) has released a new document titled:“MDS-G024 Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements.“ This guidance is designed to align the ISO 13485: 2016 Quality Management System (QMS) requirements with SFDA-MDS regulations, offering a streamlined approach for medical device compliance in Saudi Arabia. Who Should Use This Guidance? This document provides essential clarifications for various stakeholders involved in t...
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China’s NMPA Announces New Rules
27Mar 2025
News, Blogs, China admin

China’s NMPA Announces New Rules for Domestic Production of Imported Medical Devices

On March 18, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 30 of 2025, titled “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Enterprises in China.” This announcement aims to refine the regulatory framework established by the 2020 Announcement No. 104, promoting the domestic manufacturing of imported medical devices and fostering high-quality development within the industry.  C...
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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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Medical Devices in South Korea
20Mar 2025
South Korea, Blogs, General Information admin

Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is...
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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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