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Global Labelling Requirements
30May 2025
EU, Blogs, FDA, General Information, Regulations, UK, USA admin

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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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
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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Why You Need an Authorized Indian Agent for CDSCO Registration
19May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Why You Need an Authorized Indian Agent for CDSCO Registration

Entering the Indian market with medical devices requires a clear understanding of the CDSCO registration process. One of the key requirements for foreign manufacturers is to appoint an Authorized Indian Agent (IAA). But why is this step so crucial, and how can it streamline your product’s path to market? In this blog, we’ll walk you through why you need an Authorized Indian Agent for Indian medical device registration, what they do, and how partnering with an experienced agent can simplify y...
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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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