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Hi My Name Satish Mehra I noticed your medical devices and thought I’d reach out. I work with foreign manufacturers entering the Indian market, handling CDSCO approvals (MD-42 & MD-41), Sugam portal filings, and query resolution. If you’re a Manufacturer or Distributer out of India ,exploring India registration or import licensing, I’d be happy to share a quick overview or compliance roadmap. If you need any help or service pls feel free call or whatsapp me. 📲 WhatsApp: +91 8920964801 Best regards, Satish Mehra

FAQ: MD-14 Import License for Medical Devices from European Countries

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Many European medical device manufacturers (from Germany, France, UK, Netherlands, Italy, Switzerland, Ireland, Sweden, and other EU/EEA countries) want to import and sell in India’s fast-growing market. The MD-14 process (application for Form MD-15 import license) is mandatory for Class A (sterile/measuring), B, C, and D devices. Since October 2023, even most Class A devices […]

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MD-14 Import License Process | Complete Step-by-Step Guide with Full Real-World Example for US Manufacturers

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MD-14 import license process, CDSCO medical device import license, and MD-14 application for US manufacturers are the most searched terms right now as American companies rush to tap into India’s $50 billion medical device market by 2030. Whether you are exporting diagnostic kits, implants, or high-tech equipment from the US, securing the MD-14 license is

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Who Needs an MD-42 License India? Essential Guide for Medical Device Distributors and Sellers

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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,

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Step-by-Step Guide: MD-41 Application Process for Medical Device Registration Certificate (MD-42) in India (2026 Update)

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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

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What Is the MD-42 License?

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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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FDA Regulations for Software as a Medical Device (SaMD) in the United States

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Software as a Medical Device (SaMD) refers to standalone software intended to be used for one or more medical purposes (e.g., diagnosis, screening, monitoring, mitigation, treatment, or alleviation of disease) without being part of a hardware medical device. This includes mobile apps, AI/ML-based diagnostic tools, cloud-based imaging analysis software, clinical decision support systems, and other

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CDSCO Regulations for Software as a Medical Device (SaMD) in India

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Software as a Medical Device (SaMD) refers to standalone software intended to perform one or more medical purposes (e.g., diagnosis, monitoring, prediction, prevention, or treatment of disease) without being part of or embedded in a hardware medical device. This includes mobile apps, AI/ML-based diagnostic tools, cloud-based imaging analysis software, and other digital health solutions running

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Form MD-26 Details: Application for Permission to Import or Manufacture Novel Medical Devices in India

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Manufacture Novel Medical Devices – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the prescribed application form submitted to the Central Licensing Authority (CLA) within the Central Drugs Standard Control Organisation (CDSCO). It is used to seek prior permission for importing or manufacturing a novel (new or investigational) medical device that does

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MD-26 Explained: Application Form for Permission to Import or Manufacture Novel (New) Medical Devices in India

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MD-26 Explained – Under the Medical Devices Rules, 2017 (MDR 2017), Form MD-26 is the official application form submitted to the Central Licensing Authority (CLA) of the Central Drugs Standard Control Organisation (CDSCO) when seeking permission to import or manufacture a novel medical device (also called an investigational medical device or new medical device). A

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CDSCO Import License for Medical Device Manufacturing in India 2026: Full Process, Fees & Documents Required

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Importing medical devices into India for manufacturing, assembly, or further processing requires a CDSCO Import License (Form MD-15), even if the goal is local production. Under the Medical Devices Rules, 2017 (with 2025–2026 updates on perpetual validity, retention fees, and streamlined submissions), foreign manufacturers must appoint an Indian Authorized Agent to apply via the SUGAM

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