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Ankur Khare

Ankur Khare

Founder, MedReg Intel | Medical device regulatory affairs consultant

ankurkhare
India
Joined February 2026
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Summary

Deep expertise in Indian medical device regulation — particularly MDR 2017 and CDSCO processes — with practical, checklist-driven advice on import licensing (MD-14/MD-15), device classification, DMF/PMF, labeling, UDI and ISO 13485 implementation. medregintel+2
Practical educator and writer who translates regulatory requirements into actionable playbooks and series (e.g., 'MDR 2017 Made Simple'), aimed at helping startups and MedTech teams avoid common, costly compliance mistakes. medregintel+2
Founder and independent regulatory affairs consultant focused on accelerating market approvals and compliance for MedTech companies, emphasizing pre-submission checklists, document consistency, and CDSCO portal responsiveness. medregintel+1
Combines regulatory practice with interest in AI ethics and medical innovation (noted in author byline), indicating a focus on how emerging technologies intersect with device regulation and compliance. medregintel+1

Work

Education

Projects

Writing

The ₹50 Lakh Mistake Killing Indian MedTech Startups — And How to Avoid It

March 1, 2026

Explains a common regulatory mistake Indian MedTech startups make under MDR 2017/CDSCO processes that can cost large sums and delay market entry, and provides practical advice to avoid it.

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ISO 13485 for Medical Device Startups in India – What Actually Matters Under MDR 2017

February 1, 2026

Practical overview of why ISO 13485 matters for startups, what parts of the QMS are critical under MDR 2017, and common founder mistakes when implementing quality systems.

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Why CDSCO Rejects MD-14 Import License Applications — Real Reasons + How to Avoid Rejection

January 1, 2026

Detailed analysis of the most common causes for CDSCO rejection of MD-14 import license applications (documentation gaps, FSC issues, agent appointment, labeling, DMF/PMF, portal errors) with practical mitigation steps.

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MDR 2017 Made Simple: Chapter VI – Labeling & Packaging Essentials

October 1, 2025

Comprehensive guide to labeling and packaging requirements under MDR 2017, including mandatory label elements, UDI implementation, shelf life rules, import-specific labeling, and common pitfalls with solutions.

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