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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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How ISO 13485 Certification Supports SFDA Medical Device Approval
12Mar 2025
Blogs, Medical Device, SFDA, Trending Now admin

How ISO 13485 Certification Support SFDA Medical Device Approval? 

ISO 13485 certification is a crucial step in getting your medical device approved by the SFDA (Saudi Food and Drug Authority). It shows that your product meets high-quality standards and helps speed up the approval process. In this article, we’ll explain how this certification can help you meet SFDA requirements and get your device to market more quickly.  Let’s get started! Understanding ISO 13485 Certification  ISO 13485 is an internationally recognized standard that outlines...
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UDI system - South Korea's Medical Device
06Mar 2025
Blogs, South Korea, Trending Now admin

Korea’s Unique Device Identification (UDI) System: What You Need to Know? 

In recent years, South Korea has implemented a comprehensive Unique Device Identification (UDI) system for medical devices, aiming to enhance patient safety, improve traceability, and align with global standards. As of 2025, understanding and complying with the Ministry of Food and Drug Safety (MFDS) UDI requirements is essential for manufacturers and importers seeking to market medical devices in the Korean healthcare sector.  What is UDI System? The UDI system in South Korea was introduced to...
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how to prepare technical file for Saudi
04Mar 2025
Blogs, SFDA, Trending Now admin

How to Prepare a Technical File for SFDA Medical Device Registration?

A technical file for SFDA medical device registration is a key document that proves a device’s safety, quality, and compliance with the Saudi Food and Drug Authority (SFDA) regulations. A well-prepared file ensures a smoother approval process and faster market entry. This guide outlines the essential steps and best practices to compile a technical file as per SFDA’s latest 2025 requirements. What is Technical File in Medical Devices? A technical file is a structured document that includes es...
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04Mar 2025
News admin

February Newsletter 2025 – Traditional Chinese

We’re excited to bring you the latest updates and expert insights in our February 2025 Newsletter. Stay informed about key regulatory changes, industry advancements, and compliance updates in the medical device and cosmetics sectors. What’s Inside This Month? 🔹 Regulatory Updates for Medical Devices – Stay ahead with the latest changes in compliance and medical device regulations. 🔹 Cosmetics Industry Trends & Safety Standards – Discover emerging trends and updated safety requi...
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UKCA vs CE Marking
03Mar 2025
Trending Now, Blogs, UK admin

UKCA vs. CE Marking: What’s the Difference and Which One Do You Need?

In today’s global marketplace, ensuring product compliance is essential for manufacturers looking to sell in different regions. If you are marketing products in the United Kingdom (UK) or the European Union (EU), understanding the differences between UKCA and CE marking is crucial. While both markings serve as indicators of product conformity, they apply to different regulatory frameworks.  Let’s begin,  What is CE Marking?  CE marking (Conformité Européenne) is a certificat...
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SFDA Fees for Medical Devices 
16Apr 2025
Blogs, Medical Device, SFDA, Trending Now admin

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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05Mar 2025
News admin

February Newsletter 2025 – Simplified Chinese

We’re excited to bring you the latest updates and expert insights in our February 2025 Newsletter. Stay informed about key regulatory changes, industry advancements, and compliance updates in the medical device and cosmetics sectors. What’s Inside This Month? 🔹 Regulatory Updates for Medical Devices – Stay ahead with the latest changes in compliance and medical device regulations. 🔹 Cosmetics Industry Trends & Safety Standards – Discover emerging trends and updated safety requi...
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