MedReg Intel

The Two-Year Myth — Why Manufacturers Are Waiting Unnecessarily Before Filing Their India Import Licence Application By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel There is a piece of advice circulating in Indian MedTech regulatory circles that is costing manufacturers months — sometimes years — of unnecessary delay. The advice sounds reasonable. It is delivered confidently. It is repeated by experienced practitioners who genuinely believe it is correct. It is wrong. The advice is this: before filing your MD-14 import licence application in India under the free sale certificate pathway, your device needs to have been marketed in the reference country for at least two years. Manufacturers hear this and wait. They wait through their first year of EU or US marketing. They wait through their second year. They file their India application in year three — two years after they could have filed. Two years of Indian market access lost. Two y...

The Approval Sequence Nobody Tells You About — How Getting UK Approval First Can Unlock the Fastest India Regulatory Pathway By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Most overseas medical device manufacturers think about India regulatory strategy in isolation. They ask their Indian regulatory consultant: what do we need to enter India? The consultant says: CE marking or FDA clearance triggers Rule 36(3), which eliminates clinical investigation.  Or: you need to conduct clinical investigation in India.  Or: find an Indian predicate and file MD-14 under Rule 51(5). All of these answers are correct. None of them are complete. Because the most important regulatory decision for an overseas manufacturer entering India is often not made in India at all. It is made in the sequence of global regulatory approvals they choose to pursue — and specifically in whether they understand how that sequence can be engineered to unlock the ...

The Test Licence Strategy — How Rules 31 and 40 Get Any Medical Device Legally Into India in 30 Days While Your Full Licence Application Runs in Parallel By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel There is a regulatory pathway in MDR 2017 that most MedTech founders and their advisors treat as a minor administrative tool. It is not a minor administrative tool. It is a commercial strategy that converts the most expensive period in a medical device company's India journey — the regulatory waiting period — from dead time into productive time. The pathway is the test licence. The timeline is 30 days. The opportunity is the 9 to 12 months between deciding to enter India and receiving a full commercial licence — a period that most companies spend waiting when they could be building the clinical relationships, generating the early performance data, and training the key opinion leaders that determine whether their commercial launch suc...

The Predicate Device Search Most Manufacturers Never Do — How Rule 51(5) of MDR 2017 Can Replace a 5-Year Pathway With a 9-Month One By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel There is a question that should be the first question in every Indian medical device regulatory strategy conversation. It is almost never asked. The question is this: does a predicate device already exist in India for your product? The answer to that question determines whether your regulatory pathway to the Indian market takes nine months or five years. It determines whether your application requires clinical investigation in India or not. It determines whether you file Form MD-14 or Form MD-26 — and the commercial, financial, and strategic consequences of those two pathways are not comparable. Most manufacturers default to MD-26 — the investigational device pathway — without systematically checking whether a predicate device exists in India that would qua...

The Class A Manufacturing Licence You Can Get in 45 Days — Without a Single Site Audit By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel India's medical device manufacturing landscape has a problem that is entirely of its own making. Not a regulatory problem. Not a policy problem. A knowledge problem. Thousands of Indian MedTech startups and small manufacturers are waiting months — sometimes close to a year — for manufacturing licences they could have in 45 days. They are waiting for inspections that the law says are not required before the licence is granted. They are delaying product launches, burning investor runway, and losing market windows because nobody told them what Rule 20(4) of MDR 2017 actually says. This article tells them. What Most People Believe About Manufacturing Licences The standard narrative in Indian MedTech goes like this. You apply for a manufacturing licence. CDSCO or your State Licensing Authority schedu...