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Page 10
20Mar 2025
EU MDR, EU Cubicdesignz

Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: MDR All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list: Device Description and Specifications Information to be supplied by the manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management The benefit-risk analysis, the solutions adopted, and the results of t...
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Labelling Requirements
20Mar 2025
General Information admin

Labelling Requirements for Medical Devices in South Korea 

General Labelling Instructions for Medical Devices in South Korea  1.The label shall be printed in the ink, imprint, or stamp that cannot be easily erased, using Korean language in typefaces that are easy to read, such as the East Asian Gothic typeface.  1.1. Letters on the label shall not overlap with one another and shall also be in a color that is distinct from the background color, such as black letters on a white background.  2. Where a label is affixed on the container...
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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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south korea
20Mar 2025
Registrations, General Information admin

Why South Korea is a Booming Market for Medical Devices? 

South Korea has emerged as a significant player in the global medical device market, and its growth trajectory is impressive. The convergence of government support, advanced technology, a strong domestic market, and strategic trade positions South Korea as a hub for medical device innovation and investment.  Here’s an in-depth exploration of the factors contributing to this booming market.  South Korea is a Booming Market for Medical Devices 1.Government Support and Strategic Policie...
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20Mar 2025
Cosmetics admin

FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
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20Mar 2025
Events admin

ARAB Health Event – Unlocking Global Markets

The ARAB Health Event is back and ready to pave the way for groundbreaking advancements in healthcare! This year, we invite you to embark on a journey of discovery as we delve into the theme of “Unlocking Global Markets.” This extraordinary event promises to be a convergence of minds, ideas, and innovations that will shape the future of healthcare on a global scale. Discover Insights on Crucial Topics Unlocking 2024: Navigate the Current UK Landscape UAE: A Prime Market for Medical Device E...
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20Mar 2025
Events admin

OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 14 to March 17, 2024. The event, one of the largest medical exhibitions in As...
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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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arab health
20Mar 2025
Events admin

Arab Health Event 2025

OMC Medical Limited invites you to meet our team 𝑬𝒅𝒘𝒂𝒓𝒅 𝑪𝒉𝒆𝒏, 𝑵𝒊𝒌𝒐𝒍𝒐𝒂𝒔 𝑷𝒂𝒓𝒅𝒂𝒍𝒊𝒔 and 𝑪𝒉𝒊𝒅 𝑹𝒂𝒅𝒉𝒂𝒌𝒓𝒊𝒔𝒉𝒏𝒂𝒏 of Medical Device Regulatory Experts at one of the most prestigious healthcare events in the world, Arab Health 2025. Arab Health Event OMC Offer? Medical Devices & IVDs ✔ Product Registration✔ Authorized Representative Services✔ Support for Start-ups✔ Pro...
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