MedReg Intel

Make in India for Medical Devices — The Honest Truth About What Is Working, What Is Not, and What It Will Take to Build a World-Class MedTech Industry By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel India imports approximately 70 to 80 percent of its medical devices. Read that again. The world's most populous country — a nation with one of the fastest-growing economies on earth, a massive domestic healthcare need, and a government that has made manufacturing self-sufficiency a centrepiece of national policy — still depends on foreign manufacturers for most of the devices used in its hospitals every single day. The Make in India initiative for medical devices has been running for nearly a decade. The Production Linked Incentive scheme has committed thousands of crores in government support. CDSCO has been strengthened and modernised. Medical device parks have been established. And yet the import dependence persists. This is not a s...

I Analysed 100 CDSCO Rejection Letters — Here Are the Top 10 Reasons Your Medical Device Application Gets Rejected By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder- MedReg Intel Every year, hundreds of medical device applications land on CDSCO's desk. Many never make it through. Manufacturers lose months. Importers lose crores. Startups lose their entire market entry window — sometimes their entire business — because of mistakes that were entirely preventable. I have spent considerable time studying CDSCO rejection patterns, deficiency letters, and common application failures across device classes. What I found was not random. The same mistakes appear again and again, across different companies, different device categories, and different application types. This article breaks down the top 10 reasons CDSCO rejects medical device applications — with enough detail that you can audit your own submission before it ever reaches the regulator's desk...

The One Regulatory Mistake That Costs Indian MedTech Startups ₹50 Lakh and 2 Years — And How to Avoid It By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder- MedReg Intel There is a mistake so common in Indian MedTech startups that I have started calling it the Silent Killer of early stage medical device companies. It does not show up in your pitch deck. Your investors will not catch it. Your product team will not flag it. Even your legal counsel may miss it — unless they have specific medical device regulatory experience. By the time most startups discover this mistake, they have already spent ₹30 to ₹50 lakh in product development, hired a team, signed letters of intent with hospital procurement departments, and told their investors they are six months from launch. Then CDSCO sends a deficiency notice. Or worse — a rejection. And suddenly those six months become two years. This article is about that mistake. What it is, why it keeps happening, what ...

Class C Medical Device Import License in India Common Mistakes Under MDR 2017 — Practically Explained By Ankur K. Khare – Biomedical Engineer | Regulatory Affairs Specialist | Founder – RegIntel Med India Importing a Class C medical device in India is not just an application. It is a regulatory strategy decision. Under the Medical Device Rules (MDR) 2017 , Class C devices fall under moderate-to-high risk, meaning: Your documentation depth increases CDSCO scrutiny intensifies Approval timelines expand Query handling becomes critical Most delays in Class C import license applications (MD-14 / MD-15) happen due to preventable strategic mistakes. This article explains those mistakes practically — not just legally. Why Class C Import Applications Face Higher Scrutiny For Class C medical device import in India: ✔ Application is filed in Form MD-14 ✔ License is granted in Form MD-15 ✔ Device Master File (DMF) is mandatory ✔ Plant Master File (PMF) is required ✔ Indian Authorized Agent is co...