We secure your MD-15 import license, crucial for legally bringing foreign medical devices into India.
We facilitate MD-05 & MD-09 licenses, ensuring compliant manufacturing of medical devices in India.
Obtain globally recognized ISO 13485 certification (NABCB-accredited), demonstrating quality and enhancing market credibility.
We facilitate Loan Licenses (MD-6, MD-10), allowing medical device manufacturing using another's licensed facility.
Ensure your medical devices are safe and compliant through our comprehensive product testing services.
We assist in obtaining MD-13 Test Licenses for research, investigation, or testing of medical devices.
Ensure your medical devices are safe and compliant through our comprehensive product testing services.
We facilitate MD-05 & MD-09 licenses, ensuring compliant manufacturing of medical devices in India.
We are pleased to welcome you to MDR Consultants
MDR Consultants simplifies complex medical device regulations. We’re your long-term partner, guiding you from initial design to global market entry. We offer customizable solutions for every need, backed by expert advice and up-to-date industry knowledge. What truly sets us apart is our clear communication, transparency, and efficiency, ensuring timely project delivery at competitive rates. Our global reach empowers your success in any market.
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We facilitate your Non-Conviction Certificate, affirming compliance and integrity, essential for medical device industry standing.
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Obtain your Market Standing Certificate confirming product market presence, vital for international registrations and tenders.
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We secure your Neutral Code Certificate, essential for identifying devices/IVDs without disclosing proprietary information.
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We facilitate MD-42 registration for wholesalers, retailers, and distributors, ensuring compliant medical device trade operations.
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We manage Class A Manufacturing and Import Registrations (GSR 777(E)), enabling quick, compliant market entry for low-risk devices.
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Obtain your CDSCO-issued FSC, certifying your medical devices’ free sale and compliance for global export.
ExploreYour Entry to the Indian Market with MDR Consultants.
The Central Drugs Standard Control Organization (CDSCO) stands as the vigilant gatekeeper of India’s booming medical device market. Governed by the stringent Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, CDSCO’s mandate is clear: ensure every medical device entering or manufactured in India meets the highest global benchmarks for safety, quality, and efficacy.
For global and domestic innovators, navigating CDSCO’s intricate regulations – from precise device classification and exhaustive documentation to mastering the CDSCO Sugam portal and adapting to evolving guidelines – can be the most significant barrier to market entry and growth.
This is where MDR Consultants redefines the journey.
We don’t just guide you through compliance; we fast-track your success. Our deep-seated expertise and strategic insights cut through complexity, transforming regulatory hurdles into streamlined pathways. With MDR Consultants, your devices achieve rapid, confident, and enduring market access.
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In the complex world of medical device regulations, we transcend geographical boundaries and overcome intricate regulatory hurdles. We are more than just consultants; we are your ultimate partner, guiding you with unparalleled expertise to ensure your innovative medical devices achieve swift and compliant market access, anywhere in the world. Our commitment is to transform regulatory challenges into global opportunities for your success.
Your Indispensable Partner for India Market Entry
For foreign medical device manufacturers, establishing a compliant presence in the rapidly expanding Indian market is non-negotiable. The Indian Medical Devices Rules, 2017, mandates the appointment of a local Authorized Agent – a critical legal and strategic imperative.
As your designated Indian Authorized Agent, we act as the vital conduit between your organization and the Central Drugs Standard Control Organization (CDSCO). We are not merely a contact point, but your legally empowered representative, assuming responsibility for comprehensive compliance with India’s rigorous regulatory framework, including the Drugs and Cosmetics Act, 1940.
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The Brand That Promises To Turn, Your Business Around!
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Medical Device Regulatory Consultants
37-38, 1st Floor, Near Makhan Bhog, G.T. Road,
Kundli Industrial Area, Delhi NCR, 131028
CDSCO
Global Regulatory Approval
BIS (Bureau of Indian Standard)
Authorized Representative Person