CDSCO Medical Device Registration in India
Expert CDSCO consultancy services for medical device import licenses, manufacturing licenses, MDR 2017 compliance, and seamless regulatory approvals in India.
CDSCO Simplified:
Your Entry to the Indian Market
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.
Redefining 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 NKB Regovanta, your devices achieve rapid, confident, and enduring market access.
CDSCO MDONLINE SUGAM Registration
In India’s evolving medical device sector, the CDSCOMDONLINE Portal stands as the indispensable online platform for all regulatory interactions. This intuitive system is designed to simplify and accelerate your licensing journey, enabling efficient application submissions, real-time status tracking, and secure approval acquisition. Our team expertly navigates this portal on your behalf.
Our CDSCO Services
Select a service below to explore specific requirements, processes, and how our expert consultants can facilitate your regulatory approvals.
Import Registrations
End-to-end support for import-related approvals and licenses to ensure smooth and compliant market entry in India.
Class A Import Registration as per GSR 777(E)
Non-measuring & non-sterile devices.
Import License for Predicate Medical Devices
Forms MD-14, MD-15 for approved devices.
Import Authorization for Investigational Devices
Forms MD-18, MD-19 for clinical trials.
Import Authorization for Novel Medical Devices IVDs
Forms MD-26, MD-27 for new innovations.
Import Permission for IVD Clinical Evaluations
Forms MD-24, MD-25 for performance testing.
Import License for IVD Testing & Evaluation
Forms MD-16, MD-17 for quality checks.
Personal Use Medical Device Import License
Forms MD-20, MD-21 for individual patients.
Manufacturing Registrations
Complete regulatory support for setting up and licensing medical device manufacturing in India.
Manufacturing Licenses for Class C & D Medical Devices
Forms MD-7, MD-9 for high-risk devices.
Manufacturing Licenses for Class A & B Medical Devices
Forms MD-3, MD-5 for low-risk devices.
Manufacturing Registration for Class A Devices
Simplified registration as per GSR 777(E).
Loan Licenses for Class C & D Devices
Forms MD-8, MD-10 for third-party manufacturing.
Loan Licenses for Class A & B Devices
Forms MD-4, MD-6 for third-party manufacturing.
CDSCO Certificates
Official certificates and documentation that support regulatory compliance and market credibility.
MD-42 Certificate (Medical Device Registration)
Formal registration certificate from CDSCO.
Non-Conviction Certificate (NCC)
Declares no regulatory convictions on record.
Market Standing Certificate (MSC)
Proof of the product's standing in the market.
Neutral Code Certificate (Special Code)
Special coding for unbranded exports.
Free Sale Certificate (FSC)
Confirms devices are freely sold in India.
Cross-Functional & Telecommunication Services
Comprehensive outsourced retainer programs and wireless spectrum approvals across WPC, FSSAI, BIS, and CDSCO.
Drug Licenses for Importers (Form 10 & Form 41)
CDSCO registration certificates, import permits & AIR representation.
WPC Framework & ETA for Wireless Medical Devices
Equipment Type Approval (ETA), DPL licenses & RF test compliance.
PC-PNDT Certificate for Ultrasound & Imaging Devices
Statutory Form A & Form B registration under the PC-PNDT Act, 1994.
Import Export Code (IEC) & AD Code Registration
DGFT registration and ICEGATE port-wise bank AD code linking.