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Your ISO 13485 Certificate Does Not Prove MDR 2017 Compliance— Here Is What Does

What Notified Bodies Actually Check When They Say They Are Auditing ISO 13485 — The MDR 2017 Reality By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel There is a conversation that happens in almost every ISO 13485 certification project in India. The consultant tells the manufacturer — get your ISO 13485 certificate and your MDR 2017 compliance is sorted. The manufacturer spends six to twelve months and significant budget getting certified. Then the Notified Body audit happens. And three major non-compliances are raised — none of which were covered by the ISO 13485 certification process. This happens because ISO 13485 and MDR 2017 Fifth Schedule compliance are not the same thing. They are substantially aligned. But they are not identical. And the gaps between them are exactly where manufacturers get caught. This article goes deeper than the question of whether ISO 13485 is mandatory. It tells you precisely where ISO 13485 ends and MDR 2017 begi...
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What Notified Bodies Actually Check Under MDR 2017 — The Six Mandatory Audit Items Most Manufacturers Miss

What Notified Bodies Actually Check During MDR 2017 Audits — A Manufacturer's Preparation Guide By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel There is a common assumption among medical device manufacturers preparing for their first MDR 2017 audit. The assumption is this: get ISO 13485 certified, and the Notified Body audit will take care of itself. The assumption is partially right. And partially wrong in ways that create real problems during the audit process. This article tells you exactly what MDR 2017 requires Notified Bodies to check — from the primary source — and what that means for your audit preparation. What MDR 2017 Actually Says About Notified Body Audits The audit mandate for Notified Bodies under MDR 2017 comes from two places. Rule 14 — which specifies duties of Notified Bodies. The Third Schedule — which specifies the procedure Notified Bodies must follow during audits. Both are worth reading carefully before you prepar...
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MDR 2017 Does Not Mandate ISO 13485. Here Is What It Actually Requires.

Is ISO 13485 Mandatory Under MDR 2017? The Answer Is More Nuanced Than Most People Think By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel A question comes up regularly in Indian MedTech regulatory discussions. Is ISO 13485 mandatory under MDR 2017? The answer you most commonly hear is one of two things. Either — yes, ISO 13485 is mandatory for all medical device manufacturers in India. Or — no, ISO 13485 is just recommended, not required. Both answers are incomplete. And the incompleteness of each one creates practical problems for manufacturers who act on either without understanding what MDR 2017 actually requires. This article gives you the complete answer — from the primary source. What MDR 2017 Actually Says MDR 2017 does not contain the words "ISO 13485 is mandatory" anywhere in its text. Search the gazette notification G.S.R. 78(E) dated 31 January 2017 from beginning to end. You will not find a provision that ex...
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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...
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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...
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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 ...
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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...
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