India Entry Guide For Global Medical Device Companies

About the Book

India aaj duniya ke fastest-growing medical device markets mein se ek hai. Large population base, expanding healthcare infrastructure aur strong government focus jaise Make in India, National Medical Devices Policy, PLI Scheme ne India ko global medical device companies ke liye ek high-potential destination bana diya hai. Lekin is opportunity ke saath aata hai ek complex regulatory, legal aur compliance ecosystem, jise samajhna bina proper guidance ke kaafi challenging ho sakta hai.

India Entry Guide for Global Medical Device Companies foreign manufacturers ke liye ek step-by-step, practical roadmap provide karti hai jo India market entry ke har critical stage ko cover karti hai. Ye book MDR 2017 ke under CDSCO licensing, import & manufacturing requirements, quality systems, labeling, BIS/ISO standards, clinical evaluation aur post-market obligations ko clearly explain karti hai. Saath hi, ye guide regulatory compliance ko business, commercial aur operational strategy ke saath integrate karti hai—taaki India entry sirf compliant hi nahi, balki commercially successful bhi ho.

What You’ll Learn (Key Coverage)

• India Medical Device Market Overview – size, trends & growth potential

• India Entry Strategy – regulatory + commercial readiness basics

• Business Setup in India – company formation & legal structures for foreign companies

• Foreign Direct Investment (FDI) – 100% FDI policy, automatic vs approval route

• Intellectual Property (IP) Protection – patents, trademarks & technology protection

• CDSCO Licensing under MDR 2017 – import vs manufacturing pathways

• Device Classification (Class A–D) – regulatory impact on approvals

• BIS Certification & Legal Metrology – standards, labeling & packaging compliance

• Wireless (WPC), E-Waste & Environmental Compliance

• NPPA Pricing Controls – impact on medical devices

• AERB Approvals – imaging & radiation-based devices

• Distribution & Market Access – partners, tenders & localization strategies

• Post-Market Obligations – PMS, vigilance, renewals & lifecycle management

Who This Book Is For

• Global medical device manufacturers planning India entry

• International regulatory affairs & compliance teams

• Business development & market access professionals

• Importers, distributors & Indian Authorized Agents

• Legal, quality & strategy consultants in MedTech sector

Why Buy This Book

Agar aap India mein medical devices import, manufacture ya commercialize karna chahte hain, toh bina proper planning ke entry licence delays, compliance failures, pricing issues aur commercial losses cause kar sakti hai. Ye book aapko:

• India ke regulatory framework ko simple & structured way mein samajhne mein madad karti hai

• Regulatory + business perspectives ko ek integrated roadmap mein convert karti hai

• Costly mistakes, rejections aur delays se bachati hai

• Global companies ko confident, compliant aur sustainable India market entry achieve karne mein support karti hai

Author: Rajul Jain (Founder – ELT Corporate Pvt. Ltd.)
Category: Medical Device Regulation | India Market Entry | CDSCO | MDR 2017 | Global MedTech