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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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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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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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11Oct 2024
EU, Brazil, General Information, India, Swiss, UK, USA Cubicdesignz

Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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