Posts

Rule 8 MDR 2017 — The Jurisdiction Map Most Indian MedTech Manufacturers Have Never Read

The Wrong Authority Problem — How Indian MedTech Manufacturers Are Wasting Months Filing With the Wrong Regulator By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel A Class B medical device manufacturer filed their manufacturing licence application with CDSCO in New Delhi. They paid the fee. They submitted the documents through SUGAM. They waited. Four months later CDSCO informed them that Class B manufacturing licences are not issued by CDSCO. They are issued by the State Licensing Authority — the State Drug Controller of the state where the manufacturing site is located. They had been in the wrong queue for four months. Four months of investor runway consumed. Four months of delayed market entry. Four months of a mistake that a single careful reading of Rule 8 of MDR 2017 would have prevented entirely. This is not an unusual story. Versions of it happen regularly across Indian MedTech — not because manufacturers are careless but becau...
Post a Comment
Read more

The Wait That Never Needed to Happen — Rule 36(3) Has No Two-Year Marketing Requirement

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...
Post a Comment
Read more

Three Markets. One Documentation Investment. The Global Regulatory Sequence That Unlocks India in 9 Months

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 ...
Post a Comment
Read more

Your Device Can Be in Indian Hospitals in 30 Days — While Your Full Licence Application Is Still Pending

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...
Post a Comment
Read more

Your Device Probably Has an Indian Predicate. You Just Haven't Found It Yet.

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...
Post a Comment
Read more