If you’re a pharmacy owner, wholesaler, distributor, e-commerce seller, or anyone planning to stock and sell medical devices in India, you’ve probably heard about the MD-42 license. Today we’re breaking it down clearly: What exactly is an MD-42 license? Who is eligible? And what do you actually need to qualify? This is the exact info […]
If you’re a US, EU or UK-based MedTech manufacturer shipping Class A, B, C or D devices into India, this is the exact 2026 roadmap you need to clear customs, avoid costly delays, and start selling in one of the world’s fastest-growing markets. I’m guiding you through every step of the MD-15 process on the
MD-15 Import License India – Step-by-Step for US, EU & UK Manufacturers 2026 Update” Read More »
If you’re a US or EU-based MedTech executive shipping Class A, B, C, or D devices into India, this is the exact roadmap you need in 2026 to clear customs, avoid expensive delays, and start selling in one of the world’s fastest-growing markets. I’m breaking down exactly what Form MD-15 is, why every American and
fda software as a medical device guidance samd – FDA Software as a Medical Device SaMD guidance, FDA digital health updates 2026, Clinical Decision Support Software, general wellness devices, and AI in medical Software — these trending topics are making waves after the U.S. Food and Drug Administration issued fresh guidance documents in January 2026
Introduction: The Massive Opportunity in the Indian Medical Device Market India represents one of the fastest-growing healthcare markets in the world. Valued at approximately USD 16.16 billion in 2025 and projected to reach USD 44.76 billion by 2034 (CAGR of 12.2%), the medical device sector offers unparalleled opportunities for foreign manufacturers from the USA, Europe,
Get CDSCO Import License to Manufacture – Foreign manufacturers looking to import medical devices into India whether for direct sale, distribution, local assembly, or further manufacturing—must secure a CDSCO Import License (Form MD-15). Under the Medical Devices Rules, 2017 (with 2025–2026 updates including perpetual validity, retention fees, and provisions for subsequent importers/brand endorsements), foreign entities
How Foreign Manufacturers Can Get CDSCO Import License to Manufacture in India 2026 Read More »
Import license medical devices India, CDSCO Form MD-14, MD-15 import license, SUGAM portal medical devices, and CDSCO medical device import 2026 are essential for global manufacturers targeting India’s booming $15B+ medtech market. With full enforcement across all risk classes since late 2023 and perpetual validity for approved licenses, mastering the Form MD-14 process in 2026
Import License for Medical Devices in India: Complete 2026 Guide to Form MD-14 Approval Read More »
MD-42 license India requirements are a key concern for anyone involved in the medical device supply chain, especially as India’s healthcare market expands rapidly. The MD-42 Registration Certificate, introduced under the Medical Devices Rules, 2017, and reinforced by the Fifth Amendment (G.S.R. 754(E) dated September 30, 2022), is mandatory for entities handling the sale, stocking,
The MD-41 application is the official form used to apply for a registration certificate (issued as Form MD-42) to sell, stock, exhibit, offer for sale, or distribute medical devices—including in-vitro diagnostic (IVD) devices—under the Medical Devices Rules, 2017 (as amended). This is mandatory for wholesalers, retailers, distributors, stockists, pharmacies, hospitals, and diagnostic centers handling medical
The MD-42 license (also referred to as Form MD-42 or MD 42 registration certificate) is a mandatory regulatory authorization in India for entities involved in the sale, stocking, exhibition, offering for sale, or distribution of medical devices, including in-vitro diagnostic (IVD) devices. Issued under the Medical Devices Rules, 2017 (as amended by the Fifth Amendment
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