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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Explore a curated list of medical devices approved by the Central Drugs Standard Control Organization
(CDSCO),
ensuring compliance with Indian medical device regulations, safety, and quality standards.
Your 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!
MDR Consultants excels in guiding medical device companies through global regulatory approvals with tailored solutions, clear communication, and efficient delivery. Their mission-driven approach fosters innovation, compliance, and long-term partnerships built on trust and excellence.
As I observed this company maintains a very good and cooperative environment. "MDR" consultancy is equipped with all modern amenities. They guide you the best. I highly recommend this firm. The entire team is very courteous and helpful. Highly Professional team and the owner is very skilled and humble.
Outstanding expertise! They streamlined our regulatory process, saving us immense time and stress. A truly invaluable partner for medical device compliance.
MDR Consultants have been a reliable partner for our CDSCO registration needs. Their efficient processes and in-depth knowledge of the regulations saved us significant time and resources. We are confident about the quality of their services and their commitment to client satisfaction.
MDR team has consistently delivered quality work, meeting deadlines and exceeding our expectations. We really recommend MDR for regulatory support
My experience with MDR consultants is wonderful. They have in-depth and vast knowledge about their work. They have the team of incredible people. Their commitment towards the client is highly appreciable. I highly recommend to have their services.
MDR IS THE BEST SOLUTION FOR MEDICAL DEVICES CONSULTANCIE THEY PROVIDE ALL THE SOLUTIONS AND PROPER GUIDANCE.AND DELIVER THEIR SERVICES ON TIME .
MDR team has consistently delivered high quality work, meeting deadlines and exceeding our expectations.
It was really a nice experience working with MDR consultancy.They guide you properly with their tranparent work ethics.Honestly MDR consultancy helped me a lot in growing my business.
A very friendly bunch of efficient employees in the team of MDR.A very professional approach towards their job and all my work was done hassle free with least follow up from my side.Keep up great work team MDR!!!!👍👍
The services are top notch , highly recommend for Mr Ashish
Best regulatory services..for medical devices…best in the business
Have a rich experience in the field of consultancy.
Extremely helpful and responsive
Very good experience
Good Services
Appreciable work.
True consultant
Submit Your Query
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
