Launch of Innovative Medical Device in India

About the Book

India is rapidly emerging as a global hub for medical device innovation, driven by advances in digital health, artificial intelligence, remote monitoring, and indigenous R&D. However, innovation alone does not guarantee market access. Every innovative medical device must successfully navigate India’s regulatory framework governed by the Medical Device Rules (MDR), 2017 under the Central Drugs Standard Control Organization (CDSCO).

Launch of Innovative Medical Device: Practice and Procedure is a comprehensive and practice-oriented guide that bridges the gap between medical innovation and regulatory compliance. The book is designed to help innovators convert promising ideas into legally approved and commercially viable products in India.

Why This Book?

• Explains regulatory pathways for first-of-its-kind and innovative medical devices
• Clarifies CDSCO expectations for devices with no predicate approved in India
• Provides structured guidance on clinical investigations, documentation & approvals
• Addresses common challenges faced by startups and R&D-driven companies

What You Will Learn

• India’s emerging role in global MedTech innovation
• Risk-based classification of devices under MDR 2017 (Class A–D)
• Regulatory treatment of innovative and non-similar devices
• Role of predicate devices and substantial equivalence
• Clinical investigation permissions (MD-22 & MD-23)
• Import permissions for testing, training & demonstration (MD-16 & MD-17)
• Technical documentation requirements (DMF, PMF, CER)
• Import licensing pathway (MD-14 & MD-15)
• Regulatory pathway for domestically manufactured innovative devices
• Software as a Medical Device (SaMD), AI & digital health compliance
• Post-approval obligations, PMS & lifecycle compliance

Import vs Manufacturing Pathways

The book clearly differentiates regulatory obligations for:

• Imported innovative devices – from classification and clinical investigation to import licensing
• Domestically manufactured innovative devices – from design dossier to manufacturing license

Who Should Read This Book

• Medical device innovators & product developers
• MedTech startups & incubators
• Regulatory affairs & compliance professionals
• Importers & manufacturers of innovative devices
• Legal advisors & consultants in healthcare regulation
• Academics & researchers involved in device development

Why Buy This Book

• Reduces regulatory uncertainty for innovative products
• Prevents costly delays, redesigns & rejections
• Provides a clear, actionable regulatory roadmap
• Based on real-world regulatory experience & precedents
• Supports faster and compliant market entry in India

Book Details

Title: Launch of Innovative Medical Device: Practice and Procedure
Authors: Rajul Jain & Shruti Jain
Organization: ELT Corporate Pvt. Ltd.
Category: Medical Device Regulation | MDR 2017 | CDSCO | MedTech Innovation