MedReg Intel

Navigating the SUGAM Portal for Medical Device Registration in India  What the Official Guidance Does Not Tell You By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Every year, hundreds of medical device applications filed on India's SUGAM portal get stuck — not because the devices are unsafe, not because the manufacturers are incompetent, but because of avoidable errors made before a single document was uploaded. This article is not a summary of what SUGAM is. It is a practical guide to what actually happens when you use it — the decisions that matter, the errors that cost months, and the logic you need to understand to move through the system efficiently. The Real Cost of Getting It Wrong Before the guidance, two illustrative examples for your understanding is worth knowing: Case 1: A Gujarat-based importer lost 4 months on a Class B device application because the company address on SUGAM read "Industrial Area" while t...

Post-Market Surveillance in India- Why Most Medical Device Companies Are Doing It Wrong and What CDSCO Is About to Do About It By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Ask most Indian medical device companies whether they have a Post-Market Surveillance plan and they will say yes. Ask them when they last updated their Periodic Safety Update Report and the conversation gets uncomfortable. Ask them how many adverse events they reported to India's Materiovigilance Programme last year and the number is almost always zero — not because their devices had zero adverse events, but because their post-market surveillance system exists on paper and not in practice. This gap between documented obligation and actual implementation is one of the most significant compliance vulnerabilities in India's medical device industry in 2026. And it is a gap that CDSCO is actively working to close. This article explains what post-market surveillance u...

What Happens During a CDSCO Inspection — A Complete Inside Guide That Nobody Has Written Before By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Most medical device companies in India prepare for CDSCO inspections the wrong way. They scramble. They pull together documentation at the last minute. They brief their team in the 48 hours before inspectors arrive. They treat the inspection as an event rather than as an outcome of everything they have been doing — or not doing — for the past year. Then they wonder why they receive non-conformance observations. A CDSCO inspection is not a surprise test. It is a structured, predictable, systematic review of your quality management system, your regulatory compliance, and your manufacturing operations. If you know what inspectors are looking for — and in what order they look for it — you can prepare properly, perform well, and walk away with a clean inspection report. This article tells you exactly what...

CDSCO vs FDA in 2026 — The Honest Comparison Nobody Has Done By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder- MedReg Intel Every Indian MedTech professional has an opinion about CDSCO. Most of those opinions are formed by frustration — delayed approvals, deficiency notices, unclear timelines, and the persistent perception that getting a US FDA clearance is somehow more prestigious, more rigorous, and more internationally respected than a CDSCO registration. And every foreign MedTech company eyeing the Indian market has a different kind of opinion — that CDSCO is unpredictable, understaffed, and impossible to navigate without insider connections. Both sets of opinions contain some truth. Both miss a lot of it. This article is the honest comparison that the Indian MedTech industry needs but rarely gets. Not a cheerleading piece for CDSCO. Not a dismissal of India's regulatory progress. A genuine, detailed, side-by-side analysis of where these two...