Intermediate2h 12m # CDSCO Medical Device Registration Course (India) Get a medical device licence in India: CDSCO classification (Class A–D), the Indian authorised agent, import licence dossiers and post-market duties. Selling a medical device in India requires a CDSCO import license before the first unit enters the country. There is no grace period, no soft launch, and no workaround. Every notified medical device and in-vitro diagnostic device placed on the Indian market must be registered under the Medical Devices Rules 2017 — India's comprehensive regulatory framework that brought medical devices under mandatory premarket licensing for the first time. Most foreign manufacturers discover the obligation weeks before their intended launch, with none of the groundwork done. That is the most expensive way to learn. This course is the complete practical guide to CDSCO medical device registration and import licensing for the Indian market. Starting from first principles — what the Drugs and Cosmetics Act 1940 says, how the Medical Devices Rules 2017 built on it, and what the 2020 and 2023 amendments changed — the course walks you through every layer of the compliance framework. You'll learn the four-class risk classification system, how to determine which of the 37-plus notified device categories requires a mandatory license, how the Indian Authorized Agent system works and why your IAA choice can make or break your application, what a complete submission dossier looks like for each device class, and how to navigate the SUGAM portal from account setup through Form MD-14 application to the grant of your import license in Form MD-5 or MD-6. The course covers clinical evidence requirements by class, the reference country route for accelerated registration, ISO 13485 and Schedule M-III quality management obligations, post-market surveillance and adverse event reporting, labeling requirements under Schedule 7, Software as a Medical Device under the 2025 CDSCO SaMD guidance, and the penalty framework under the Drugs and Cosmetics Act. Three worked examples — a multinational importing Class B diagnostic equipment, a startup navigating a Class C device, and an Indian manufacturer adding a notified Class A device to their range — make the framework concrete. Nine downloadable templates make it actionable from day one. Built on Krono's regulatory database — the same data that powers our free compliance roadmap tool for 213 product types across CE/EU, UK, US, and India markets. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 9 downloadable resources included ## What you'll learn * Appoint and manage an Indian Authorized Agent who can represent you before CDSCO * Build a complete submission dossier — Device Master File, Plant Master File, ISO 13485, Free Sale Certificate * Navigate the SUGAM portal end-to-end from account setup through Form MD-14 to import license grant * Understand clinical evidence requirements and the reference country accelerated route * Manage post-market surveillance, adverse event reporting, and Field Safety Corrective Actions * Label medical devices correctly under Schedule 7 of MDR 2017 with required Indian language fields * Avoid the most common CDSCO application failures and respond effectively to regulatory queries ## Requirements * ·No prior medical device regulatory knowledge required — the course builds from first principles * ·Familiarity with basic business and import/export operations is helpful but not required * ·Engineers, regulatory affairs professionals, operations managers, and founders at medical device companies will all benefit $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: India's Medical Device Compliance Landscape — The Big Picture](#lesson-2be774cf-633c-4581-8586-677a02844af7) * Understand the complete legal framework — Drugs and Cosmetics Act 1940 and Medical Devices Rules 2017 * Classify any medical device or IVD into the correct CDSCO risk class (A, B, C, or D) * Determine whether your device is on the notified list and requires a mandatory import license Includes the ebook edition, free — read it in your [library](/platform/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Course content 15 modules·132 min total The India Medical Device Market — Why CDSCO Matters Now Preview10 min The Legal Architecture — Drugs and Cosmetics Act to MDR 2017 10 min Device Classification — The Four Risk Classes 12 min The Notified Device List — What Must Be Licensed 7 min The Indian Authorized Agent — Your Gateway to CDSCO 8 min The Document Dossier — Building Your Submission Package 10 min The SUGAM Portal — Import License Application End-to-End 11 min Clinical Evidence and Testing Requirements 10 min Manufacturing Quality Standards — ISO 13485 and Schedule M-III 11 min Post-Market Obligations — Vigilance, PMS, and Renewals 10 min Labeling, In-Vitro Diagnostics, and Software as Medical Devices 9 min Penalties, Enforcement, and Common Failures 7 min End-to-End Walkthroughs and Worked Examples 10 min Building Your CDSCO Compliance Programme 8 min What's Next 0 min Enroll — $199.00 Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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