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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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CDSCO Fee & License Fee for Medical Device Registration

Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is understanding the associated registration and import license fees. These fees vary based on the classification of your device and the nature of your operations. This guide provides a detailed overview to help you navigate the financial aspects of the regulatory process. CDSCO Registration Fees for Medical Devices The regist...
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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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Top 7 Challenges in UAE Medical Device Registration(and Solutions)

You’ve got a medical device ready for the UAE market—everything from quality certifications to technical documentation is in place. But just as you start the registration process, the real challenge begins.Suddenly, you’re navigating a sea of forms, portals, and changing regulations. The process feels unclear, the requirements keep shifting, and your timeline starts slipping. Sound familiar? You’re not alone. Many manufacturers and importers face similar frustrations when dealing wit...
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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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8 Requirements for Post-Market Surveillance of Medical Devices in Saudi Arabia

Post-market surveillance (PMS) plays a critical role in maintaining the safety, quality, and performance of medical devices available in Saudi Arabia. The Saudi Food and Drug Authority (SFDA) enforces clear and structured requirements under the “Medical Devices – Post Market Surveillance Requirements” (MDS-REQ 11) to ensure ongoing monitoring once devices are placed on the market. This article outlines the key PMS requirements that manufacturers, authorized representatives, importe...
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What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
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