MedReg Intel

CE Certificate vs Free Sale Certificate — How Rule 36(3) of MDR 2017 Determines Your India Import Licence Timeline By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel If you are an overseas medical device manufacturer with CE marking, or an Indian authorised agent representing one, there is a provision in MDR 2017 that changes your India market entry calculation fundamentally. It is not obscure. It is not a technicality. It is a clear, unambiguous provision in Chapter V of MDR 2017 — the chapter governing import of medical devices — that eliminates the clinical investigation requirement for devices approved in specific reference countries. Understanding it correctly — and applying it with the right document — is the difference between a regulatory pathway measured in years and one measured in months. The Standard Import Pathway and Its Cost The standard pathway for importing a Class C or Class D medical device into India is demanding. R...

The Clock Is Running — How MDR 2017's Deemed Approval Provisions Can Save Your Medical Device Launch Months of Waiting By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Every medical device company operating in India has experienced some version of this situation. You file an application with CDSCO or your State Licensing Authority. You submit the documents. You pay the fee. You wait. Weeks pass. Then months. No approval. No rejection. No communication at all. So you wait more. You send polite follow-up emails. You make calls. You hear that the file is under review. You keep waiting. Meanwhile your product launch is delayed. Your clinical partners are losing patience. Your investors are asking questions you cannot answer. Your competitors — many of them importers with established registrations — are selling into the market you are trying to enter. This situation is frustrating. It is also, in many cases, legally unnecessary. MDR 2...

Device Master File (DMF) — What CDSCO Actually Expects By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel The Device Master File is the single most important document in any CDSCO application. It is also the document most frequently responsible for deficiency notices. Not because manufacturers are careless. Because nobody clearly explains what a DMF actually needs to contain — and what it needs to avoid. This article is that explanation. What the DMF Is — and What It Is Not The Device Master File is a structured compilation of all technical information about your device. It tells CDSCO's reviewer everything they need to know to assess whether your device is safe, effective, and manufactured to a consistent standard. It is not a product brochure. It is not a collection of certificates. It is not a summary of your device's features. A DMF is a technical argument — built from evidence — that your device does what you say it does,...

How to Respond to a CDSCO Deficiency Notice — What Most Manufacturers Get Wrong By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Most CDSCO deficiency notices are not regulatory problems. They are documentation problems — and the response to them is where applications are won or lost. A deficiency notice arriving in your inbox is not a rejection. It is a request for clarification. How you respond determines whether your application moves forward or enters another cycle of delay. What a Deficiency Notice Actually Is CDSCO raises deficiency notices as numbered lists of specific queries or requests for additional information. Each item corresponds to something the reviewing officer found incomplete, inconsistent, or unclear in your submission. The notice is structured. Your response must be equally structured. This sounds straightforward. In practice, most deficiency responses fail not because the manufacturer lacks the information, but...

Your FDA Clearance Is Not a Predicate in India- What Global Manufacturers Get Wrong By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel Most medical device companies entering India make the same assumption. "We have FDA clearance. We have a predicate. India will be straightforward." It is not straightforward. And the misunderstanding costs months — sometimes years. The Assumption That Breaks Applications When a manufacturer has US FDA 510(k) clearance, they have demonstrated substantial equivalence to a predicate device — a device previously cleared by FDA in the United States. That US predicate has no standing in India. India's regulatory framework under MDR 2017 defines predicate device independently, in Rule 3(zm): "A device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar Intended Use, Material of Construction and Design Cha...