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Quality Assurance for Medical Equipment in UAE
19Mar 2025
UAE, Blogs, Trending Now admin Comments: 0

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 Comments: 0

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 Comments: 0

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
11Mar 2025
Blogs, Medical Device, SFDA, Trending Now admin Comments: 0

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 Comments: 0

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 Comments: 0

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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UKCA vs CE Marking
03Mar 2025
Trending Now, Blogs, UK admin Comments: 0

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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medical device regulations standards in China
20Feb 2025
China, Trending Now admin Comments: 0

How to Ensure Your Medical Device Meets China’s Regulatory Standards? 

China’s medical device market is one of the largest and fastest-growing in the world, making it an attractive destination for manufacturers. However, navigating the complex regulatory landscape set by the National Medical Products Administration (NMPA) can be challenging. This guide outlines the key steps to ensure your medical device complies with China’s regulatory requirements, from initial planning to post-market surveillance.  Key Regulatory Body:  Understand China’s Medical...
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Medical Device Regulatory Framework in China
19Feb 2025
China, Trending Now admin Comments: 0

China’s Medical Device Regulatory Framework and NMPA Guidelines 

China has emerged as one of the largest and fastest-growing markets for medical devices, making regulatory compliance essential for manufacturers looking to enter this competitive landscape. The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), oversees the regulation of medical devices in China. Understanding the NMPA’s regulatory framework and guidelines is crucial for ensuring smooth market entry and compliance.  The NMPA opera...
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china medical device quality control
19Feb 2025
China, Trending Now admin Comments: 0

 How to Ensure Medical Device Safety in China? Quality Control Standards

China’s medical device market is one of the largest and fastest-growing in the world. However, ensuring compliance with the country’s strict quality control standards is essential for manufacturers seeking market approval. This guide provides an in-depth look into China’s medical device quality control requirements and offers tips on maintaining high standards to ensure product safety and regulatory approval.  Let’s begin, Understanding China’s Regulatory Framework The Nationa...
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