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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
26Mar 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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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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28Feb 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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27Feb 2025
News admin

February Newsletter 2025 – Japanese

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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27Feb 2025
News admin

February Newsletter 2025 – English

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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January Newsletter 2025
31Jan 2025
News admin

January Newsletter 2025- Korean

Stay Updated with the Latest Industry Insights We look forward to sharing the latest updates and insights in our January Newsletter 2025. Stay informed about the most recent advancements and regulatory changes in the medical device and cosmetics industries. What’s Inside the January Newsletter 2025? For more details, read our full newsletter here: January Newsletter 2025 – Korean...
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