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Medical device

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Tag: Medical device
14Jul 2025
EU, Cosmetics admin

Understanding Borderline Cosmetics in the EU

by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regul...
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30May 2025
News admin

December Newsletter 2024 – Chinese Simplified

We look forward to sharing the latest updates and insights in our December Newsletter 2024 – Chinese Simplified. December Newsletter 2024 What’s inside in December Newsletter 2024 – Chinese Simplified? Please read below for more information December Newsletter 2024 – Chinese Simplified...
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China International Medical Equipment Fair
20Mar 2025
Events admin

China International Medical Equipment Fair

CMEF, 2024 The China International Medical Equipment Fair (CMEF) is one of the largest and most influential medical equipment exhibitions in Asia, bringing together healthcare professionals, manufacturers, distributors, and innovators from around the world. Held biannually, CMEF showcases a wide array of medical devices, diagnostics, imaging systems, wearables, and other healthcare solutions. It serves as a platform for product launches, industry networking, and gaining insights into advancement...
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kimes busan
20Mar 2025
Events admin

KIMES Busan Medical & Hospital Equipment Show

The KIMES Busan Medical & Hospital Equipment Show is a premier event in South Korea’s medical industry, showcasing the latest advancements in medical technology, hospital equipment, and healthcare solutions. Held annually in Busan, KIMES Busan attracts healthcare professionals, medical equipment manufacturers, and industry leaders from around the world, creating an ideal platform for networking, discovering new technologies, and expanding knowledge in the healthcare sector. Key Highlights...
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10Mar 2025
FDA, EU, EU MDR, Regulations, USA Cubicdesignz

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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06Mar 2025
China, Blogs, Trending Now admin

Step by Step Process in Medical Device Registration China

Registering medical devices in China is a complex and highly regulated process governed by the National Medical Products Administration (NMPA). Manufacturers seeking market entry must comply with stringent regulatory requirements to ensure safety, efficacy, and compliance.   The Centre for Medical Device Evaluation of NMPA (CMDE) shall be responsible for the application for clinical trials of medical devices requiring clinical trial approval, and the technical evaluation of the registration ap...
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medical device regulations standards in China
20Feb 2025
China, Trending Now admin

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
20Feb 2025
China, Trending Now admin

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

 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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UK Medical Device Registration Process
14Feb 2025
Medical Device, Trending Now, UK admin

UK Medical Device Registration: Everything You Need to Know  When it comes to introducing your medical device to the UK market, compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) is a must. The MHRA is responsible for ensuring that all medical devices in the UK meet the highest standards of safety and efficacy.  In this guide, we’ll walk you through everything you need to know about the United kingdom Medical Device Registration process, from the initial c...
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