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eifu guidelines for medical devices in saudi
21Apr 2025
Trending Now, Blogs, Saudi Arabia, SFDA admin

e-IFU Guidelines for Medical Devices in Saudi Arabia 

Imagine you’re a healthcare professional in Riyadh, mid-procedure, and you urgently need access to a device’s instructions. Instead of flipping through a bulky printed manual, you scan a QR code on the device. Within seconds, the most up-to-date instructions appear on your tablet. That’s the power and convenience of Electronic Instructions for Use (e-IFU). Not long ago, when someone bought a medical device, it came with a thick instruction manual—usually in multiple languages, pa...
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Saudi AR License Renewal Fees Process
16Apr 2025
Blogs, Authorised Representatives, Medical Device, Saudi Arabia, SFDA, Trending Now admin

Saudi AR License Renewal Fees & Process for Medical Devices

Staying compliant with the Saudi Food and Drug Authority (SFDA) is crucial for maintaining uninterrupted market access for medical devices in Saudi Arabia. One of the key regulatory requirements is ensuring timely renewal of the Authorized Representative (AR) license along with understanding the applicable SFDA fee for medical device representation. This guide outlines the SFDA AR license renewal process, the applicable fees, and important timelines to help manufacturers and their representative...
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Clinical Evaluation vs Clinical Study
10Apr 2025
Blogs, Regulations, Trending Now admin

Clinical Study vs. Clinical Evaluation: What’s the Difference in Medical Device Regulation? 

In the medical device industry, the terms clinical study and clinical evaluation are often used interchangeably—yet they serve very different purposes. Understanding the distinction between the two is crucial for manufacturers aiming to obtain and maintain regulatory approval in key markets like the EU and UK. This article breaks down the difference between clinical study and clinical evaluation, and explains when and why each is required.  What is a Clinical Evaluation? A clinical evalua...
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What is medical translations
08Apr 2025
Blogs, Translations, Trending Now admin

What Is Medical Translation and Why Is It Critical? 

When it comes to healthcare, there’s no room for miscommunication. Whether it’s medical research, pharmaceutical products, clinical trials, or regulatory documentation, information often needs to cross linguistic and cultural lines. That’s where medical translation comes in — a highly specialized field that plays a crucial role in delivering safe and effective healthcare worldwide.  What is Medical Translation? Medical translation refers to the process of accurately converting m...
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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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Import License for Medical Devices in India
24Mar 2025
Blogs, CDSCO, India, Trending Now admin

Import License for Medical Devices in India 

India’s medical device industry is growing rapidly, with both domestic manufacturing and international imports driving the sector forward. However, importing medical devices into India requires compliance with strict regulatory frameworks governed by the Central Drugs Standard Control Organization (CDSCO). One of the critical steps in this process is obtaining a Medical Device Import License India. Let’s walk through what this means, why it’s important, and how forms like Form MD-14 and Fo...
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