Make in India for Medical Devices

About the Book

India ka MedTech sector fast grow kar raha hai, lekin aaj bhi 75–80% medical devices imports par depend hain. Is gap ko bridge karne ke liye government initiatives jaise Make in India, PLI Scheme, Medical Device Parks aur National Medical Devices Policy 2023 push kar rahe hain—par industry ka core question abhi bhi wahi hai: “India really manufacture kar raha hai ya sirf assemble?”

Make in India for Medical Devices: A Complete Guide to the Scheme – Assemble or Manufacture isi debate aur compliance journey ko crystal-clear banati hai. Ye book MDR 2017 ke under aapko regulatory, licensing, plant documentation, quality systems, testing, labeling, clinical evidence aur post-market obligations ka end-to-end roadmap deti hai—easy explanations, practical guidance aur real-world context ke saath.

What You’ll Learn (Key Coverage)

• Device Classification (Class A to D) – risk-based classification simplified

• Licenses that matter – Manufacturing (MD-5/MD-9), Import (MD-15), Wholesale (MD-42) & compliance meaning

• Plant readiness – PMF & DMF made simple (what to write, what to maintain)

• Safety & Quality – ISO 13485:2016 QMS, CAPA, audits, traceability essentials

• Testing & Standards – BIS / NABL / ISO, lab realities, common hurdles

• Labeling, Packaging & UDI – mistakes that cause delays/rejections

• Clinical evidence & Post-market vigilance – when trials are needed, reporting & recall basics

• Assembly vs True Manufacturing – MDR line, risks of “assembly in disguise”

• Growth opportunities – PLI benefits, device parks, exports strategy, SaMD (Software as a Medical Device)

Who This Book Is For

• Medical device manufacturers & assemblers

• Startups/MSMEs entering MedTech

• Importers, distributors & regulatory affairs teams

• Investors, incubators & policymakers

• Quality/Compliance professionals building MDR 2017 readiness

Why Buy This Book

Agar aap “Make in India” ecosystem mein medical devices launch/scale karna chahte hain, toh ye guide aapko compliance se lekar strategy tak ek structured path deti hai—taaki aap costly mistakes, delays aur licensing rejection se bach sakein aur assembly se innovation-driven manufacturing ki taraf move kar sakein.

Authors: Rajul Jain & Shruti Jain (Founders – ELT Corporate Pvt. Ltd.)
Category: Healthcare | Medical Device Regulatory | MDR 2017 | Make in India | PLI Scheme