Form MD-14 is the official application form used to apply for an Import License (Form MD-15) for medical devices in India under the Medical Devices Rules, 2017. Only an Authorized Indian Agent (a company holding a valid wholesale or manufacturing license in India) can apply on behalf of a foreign manufacturer. Foreign companies cannot apply […]
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In today’s global marketplace, businesses frequently export products, establish international partnerships, and expand operations across borders. To ensure that official documents are recognized and accepted in foreign countries, embassy legalization is often a mandatory requirement. If your export documents need embassy legalization, professional assistance can help you complete the process accurately and efficiently. What Is
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New Enforcement on Query Responses and Export Simplifications Aim to Reduce Backlogs and Boost Ease of Doing Business NEW DELHI — The Central Drugs Standard Control Organization (CDSCO) continues to strengthen the SUGAM Portal as the primary digital gateway for medical device, drug, and clinical trial approvals in India. Several key updates rolled out in
What is the SUGAM Portal? Complete 2026 Guide for Medical Device & Drug Manufacturers CDSCO’s Digital Platform Streamlining Regulatory Approvals in India NEW DELHI — The SUGAM Portal has become the backbone of India’s medical device and pharmaceutical regulatory system. Launched by the Central Drugs Standard Control Organization (CDSCO), this single-window online platform allows manufacturers,
If you’re a manufacturer, importer, or regulatory professional shipping medical devices into India, understanding Form MD-15 is crucial to ensure your shipments are compliant and avoid delays. Today, we’re doing a complete deep dive into exactly what Form MD-15 is, why it matters, how you get it, and what the process looks like in 2026.
What Exactly is Form MD-15 worldwide 2026? Read More »
Medical Device Registration – Securing CDSCO Approval via MD-14 Import LicenseUS medical device manufacturers face a high-potential yet complex opportunity in India, one of the world’s fastest-growing healthcare markets. With rising demand for advanced diagnostics, implants, surgical tools, and digital health solutions, India’s medical device sector is expanding rapidly. However, compliance with the Central Drugs
Step-by-Step Guide to Medical Device Registration India for US Manufacturers 2026 Read More »
MD-14 Import License for Medical Devices in India: The No-BS Guide That Gets Your Shipments Moving Ever watched a container of critical ventilators or stents sit idle at Mumbai port for weeks because one form didn’t line up? Here’s the truth: without the right MD-14 import license from India’s CDSCO, your medical devices don’t clear
How to apply for MD-14 import license for medical devices in India 2026 Read More »
if you’re in pharma, medical devices, biologics, cosmetics or food, and you want faster CDSCO approvals, licenses, or full regulatory compliance in India… Delhi is the strategic hub where opportunities come together. Because Delhi is the Regulatory Capital of India, hosting the CDSCO headquarters at the FDA Bhawan, it offers faster approvals and direct access
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If you’re exporting cars, two-wheelers, three-wheelers, EVs, or automotive components into India, this is non-negotiable. Let’s break it down clearly, step by step, like we always do. What is TAC Approval / TAC Certificate? TAC stands for Type Approval Certificate (sometimes called CMVR Type Approval). It’s an official certification issued by the Indian government proving
If you’re importing, manufacturing, selling, or distributing anything from bandages and BP monitors to implants, stents, or diagnostic kits, you’ve probably asked this exact question: Does a medical device require registration in India? The answer in 2026 is crystal clear: YES – almost every single medical device now needs official CDSCO registration or licensing before
