Guide on Medical Device Certifications

About the Book

Navigating India’s healthcare regulatory framework can be challenging due to multiple laws, forms, digital portals, and evolving compliance requirements.
Complete Guide to CDSCO Approvals: Drugs, Cosmetics & Medical Device Registrations is a comprehensive handbook designed to simplify
CDSCO registrations, licenses, and compliance processes for industry professionals and newcomers alike.

This book provides a structured and practical explanation of regulatory pathways for
drugs, cosmetics, and medical devices, along with detailed guidance on documentation, procedures, timelines, and common regulatory pitfalls.
A unique feature of this guide is the inclusion of a CDSCO & State FDA Directory, making it a ready reference for regulatory coordination.

Why This Guide?

• Simplifies complex CDSCO regulatory procedures
• Explains licenses, registrations, and approvals in a step-by-step manner
• Reduces risk of delays, rejections, and non-compliance
• Serves as both a learning tool and a practical compliance manual

What You Will Learn

• Role, structure & authority of CDSCO
• Drugs & Cosmetics Act, 1940 and Medical Device Rules (MDR), 2017
• CDSCO digital portals – SUGAM, MD Portal, ONDLS & NSWS
• Drug Import Registration Certificate (Form 41)
• Drug Import License (Form 10)
• Drug manufacturing, loan & test licenses
• New drug registration & special drug services
• Medical device risk classification (Class A–D)
• Medical device import, manufacturing & test licenses (MD forms)
• Software as a Medical Device (SaMD) registration
• Clinical trial permissions & CRO registration
• Cosmetics import, manufacturing & loan licenses
• Laboratory, ethics committee & other CDSCO services
• Industry case studies & international regulatory context
• CDSCO & State FDA directory

Who Should Read This Book

• Pharmaceutical manufacturers & importers
• Medical device & IVD companies
• Cosmetics manufacturers & brand owners
• Regulatory affairs & compliance professionals
• Healthcare startups & entrepreneurs
• Students pursuing regulatory careers
• Healthcare legal & regulatory consultants

Why Buy This Book

• Provides clear regulatory clarity across all CDSCO-regulated products
• Helps avoid costly compliance mistakes and approval delays
• Acts as a ready reference for day-to-day regulatory work
• Based on practical regulatory experience and real-world cases

Book Details

Title: Complete Guide to CDSCO Approvals: Drugs, Cosmetics & Medical Device Registrations
Authors: Rajul Jain & Shruti Jain
Organization: ELT Corporate Pvt. Ltd.
Category: Healthcare Regulatory | CDSCO | Drugs & Cosmetics | Medical Devices | MDR 2017