MDR Consultants

Welcome to MDR Consultants – Your Trusted Medical Device Regulatory Partner

MDR Consultants is a leading regulatory consulting firm helping medical device manufacturers, importers, distributors, and startups navigate complex regulatory requirements in India and global markets.

We specialize in end-to-end regulatory solutions, including:
CDSCO Import License (MD-15)
Medical Device Manufacturing License (MD-05, MD-09)
Product Classification & Registration
Technical Documentation & Regulatory Submission
ISO 13485 Quality Management System Support
BIS Certification
CE Marking (EU MDR)
US FDA Establishment Registration & Device Listing
Regulatory Documentation and Compliance Support

On this channel, we share the latest regulatory updates, CDSCO notifications, compliance requirements, industry news, and important information to help businesses stay informed about medical device regulations and market access.