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30May 2025
EU MDR, Regulations Cubicdesignz

EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe

Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR arises from various factors, including shortcomings identified in the previous regulatory framework (Medical Device Directives) and the evolving landscape of medical technologies. Rapid technological advancements in the field of medi...
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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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30May 2025
Events admin

Bio Korea 2024 – The Future of Biotechnology Innovation and Global Collaboration

Join Us at BIO KOREA 2024 – Advancing Global Bio-Health Innovation Every year, BIO KOREA organizes the International Convention with the goal of promoting and expanding the bio-health sector worldwide. We are happy to announce that the 19th BIO KOREA will take place at COEX in Seoul from May 8–10, 2024. This year too. Get the chance to network with international academics, professionals, and CEOs in the bio-health field, as well as exchange the latest trends and technologies in the field thr...
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Medical Device Grouping in India
22May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Medical Device Grouping in India 

As India improves its rules for medical devices, it’s important to know how products are grouped when they are registered. The Central Drugs Standard Control Organization (CDSCO) has created clear guidelines for grouping medical devices. This helps make the submission process easier, avoids repeating work, and makes the rules clearer. Grouping allows manufacturers to organize similar products better, making the approval process smoother and more predictable. What is Medical Device Grouping in...
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Challenges in CDSCO registration in India
16May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

6 Challenges in CDSCO Registration & How OMC Solves Them

Getting medical devices approved for the Indian market involves more than just paperwork. CDSCO follows strict guidelines, and if you’re not familiar with how it works, the process can feel overwhelming. Whether you’re a local manufacturer or a foreign company trying to import your product into India, there are common hurdles you’re likely to face. In this blog, we break down the main challenges in CDSCO registration—and show how OMC Medical can help you solve them, step by step....
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Post Market surveillance (PMS) requirements in SFDA
13May 2025
Blogs, Saudi Arabia, SFDA, Trending Now OMC Medical Limited

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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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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CDSCO-Fee-License-Fee-for-Medical-Device-Registration
12May 2025
Blogs, CDSCO, Medical Device, Trending Now OMC Medical Limited

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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08May 2025
Regulations, Blogs, CDSCO, India, Trending Now admin

Medical Device Registration Process CDSCO

If you plan to sell medical devices in India—either as a local manufacturer or a foreign company—you must register your product with the Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory authority responsible for ensuring the safety, quality, and performance of medical devices and drugs. In this guide, we explain the CDSCO registration process step by step, including recent updates in 2025, required documents, timelines, and key responsibilities for...
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