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News May 30, 2025 OMC Medical Limited

April 2025 Newsletter (English)

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: April 2025 Newsletter 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 ISO...
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30May 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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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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CDSCO Releases Addendum Clarifying Key Aspects of Medical Devices Rules 
30May 2025
News OMC Medical Limited

CDSCO Releases Addendum Clarifying Key Aspects of Medical Devices Rules 

The Central Drugs Standard Control Organization (CDSCO) has issued a new addendum (No. 0152), dated April 3, 2025, This article provides additional clarity on several regulatory requirements, helping manufacturers and stakeholders better navigate India’s medical device regulatory framework. CDSCO Releases Regulatory Update  Clarification on Biocompatibility Testing  The addendum emphasizes that all medical devices that come into direct or indirect contact with the human body must comply...
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12May 2025
Medical Device, News, Swiss, Trending Now OMC Medical Limited

New MIR Form 7.3.1 Accepted by Swissmedic: Key Updates for Medical Device Manufacturers

On May 5, 2025, the European Commission released version 7.3.1 of the Manufacturer Incident Report (MIR) form used for reporting serious incidents involving medical devices. This updated version reflects the latest EU requirements for post-market surveillance and incident reporting.  Swissmedic, the Swiss authority responsible for monitoring medical device safety, has confirmed that MIR version 7.3.1 is now accepted for incident reporting in Switzerland—provided the form is completed in accor...
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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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28Mar 2025
News admin

March 2025 Newsletter (Japanese)

We’re back with essential updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what you’ll find in this edition: ✔ Regulatory Updates for Medical Devices – Stay informed about the latest compliance requirements and policy changes. 💡 Cosmetics Industry Trends & Safety Standards – Explore new developments and evolving safety guidelines shaping the cosmetics sector. 📂 ISO Standards & Compliance – Learn how recent ISO...
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27Mar 2025
News admin

March 2025 Newsletter (English)– Stay Ahead in the Regulatory World

We’re back with the latest updates, expert insights, and key compliance changes in the medical device and cosmetics industries. Here’s what’s inside this month’s edition: 📌 Regulatory Updates for Medical Devices – Stay up to date with the latest compliance requirements and regulatory shifts. 📌 Cosmetics Industry Trends & Safety Standards – Explore new trends and evolving safety guidelines shaping the cosmetics sector. 📌 ISO Standards & Compliance – Understand the l...
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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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Medical Device Lifecycle Management
25Mar 2025
News, General Information, Trending Now admin

Why Lifecycle Management Matters for Medical Devices? 

The medical device industry operates in a highly regulated environment where safety, efficacy, and compliance are critical. To ensure devices remain safe and effective throughout their lifespan, manufacturers must adopt a robust lifecycle management approach. This article explores why lifecycle management matters for medical devices and how it benefits manufacturers, healthcare providers, and patients.  Understanding Medical Device Lifecycle Management  Medical device lifecycle management...
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