India CDSCO Medical Device Registration & Licensing Consultant
Navigate India's CDSCO regulatory framework with confidence. NexorTest Technologies provides end-to-end medical device registration consulting — from device classification and documentation to SUGAM portal submission and license issuance — for Class A through Class D devices, IVDs, and SaMD.
India CDSCO Medical Device Registration & Licensing Consultant
Navigate India's CDSCO regulatory framework with confidence. NexorTest Technologies provides end-to-end medical device registration consulting — from device classification and documentation to SUGAM portal submission and license issuance — for Class A through Class D devices, IVDs, and SaMD.
Four Risk-Based Device Classes Under MDR 2017
CDSCO classifies all medical devices into four risk categories. Your device class determines the registration pathway, documentation requirements, and review timeline.
Class A Devices
Lowest-risk devices including tongue depressors, bandages, examination gloves, and reusable surgical instruments. Non-sterile, non-measuring Class A devices can be self-notified.
- 1-2 Weeks
- Form MD-14
- Self-Notification
How is Class A registration different?
Non-sterile, non-measuring Class A devices only require self-notification on the SUGAM portal. Sterile or measuring Class A devices must undergo full CDSCO review via Form MD-14.
Class B Devices
Low-moderate risk devices such as hypodermic needles, surgical gloves, powered wheelchairs, and blood administration sets. Requires CDSCO review and approval.
- 3-6 Months
- Form MD-14
- CDSCO Review
What testing is needed for Class B?
Class B devices require performance testing, biocompatibility assessment (if applicable), and ISO 13485 QMS certification. Test reports must be from NABL/ISO 17025 accredited labs.
Class C Devices
Moderate-high risk devices including ventilators, dialysis machines, infusion pumps, and bone fixation plates. Requires detailed clinical evidence and CDSCO expert committee review.
- 6-9 Months
- Form MD-15
- Expert Review
Is clinical data required for Class C?
Yes. Class C devices require clinical evidence demonstrating safety and performance. This may include clinical investigation data, published literature, or equivalent device comparisons per MDR 2017 Schedule V.
Class D Devices
Highest-risk devices including cardiac stents, implantable defibrillators, heart valves, and hip implants. Subject to the most rigorous CDSCO review and may require Indian clinical trials.
- 9-15 Months
- Form MD-15
- Stringent Review
Do Class D devices need Indian clinical trials?
Class D devices may require clinical investigations conducted in India, depending on the device type and available global clinical evidence. CDSCO can waive this requirement based on risk-benefit assessment and data from stringent regulatory authorities.
Comprehensive CDSCO Registration Services
From initial classification through post-market surveillance, NexorTest manages every aspect of your CDSCO regulatory journey.
CDSCO Class A/B Registration
Complete Form MD-14 preparation and submission for low and low-moderate risk devices. Includes self-notification management for non-sterile, non-measuring Class A devices and full CDSCO review support for Class B.
CDSCO Class C/D Registration
End-to-end Form MD-15 management for moderate-high and highest-risk devices. Includes clinical evidence compilation, expert committee preparation, query resolution, and manufacturing/import license acquisition.
SUGAM Portal Submission
Expert management of the entire SUGAM portal (cdscoonline.gov.in) workflow including account setup, document uploads, fee payments, application tracking, and query response management.
BIS Certification
Bureau of Indian Standards certification for notified medical device categories. Includes product testing at BIS-recognized labs, factory inspection coordination, and ISI mark license acquisition for mandatory compliance.
ISO 13485 QMS Implementation
Full implementation of ISO 13485 Quality Management System required for CDSCO registration. Gap analysis, documentation development, internal audit support, and certification body coordination.
IVD Registration India
Specialized In Vitro Diagnostic device registration covering IVD-specific risk classification, analytical and clinical performance evaluation, reagent documentation, and CDSCO submission for all IVD categories.
SaMD Regulatory Pathway
Software as a Medical Device regulatory strategy for India. Covers software lifecycle documentation (IEC 62304), cybersecurity risk assessments, AI/ML validation, and CDSCO's evolving digital health requirements.
Import & Manufacturing License
Acquisition of import licenses for foreign manufacturers and manufacturing licenses for Indian producers. Includes authorized agent appointment, factory inspection preparation, and license maintenance with 5-year retention fees.
Post-Market Surveillance
Comprehensive post-market surveillance and vigilance reporting systems. Includes adverse event reporting to CDSCO, periodic safety update reports (PSURs), field safety corrective actions, and regulatory compliance monitoring.
India's Trusted CDSCO Specialist
We combine deep local regulatory expertise with global experience to deliver faster, more predictable CDSCO approvals.
India's Leading CDSCO Specialist
Local regulatory team with direct experience navigating CDSCO processes, state drug controllers, and SUGAM portal intricacies. We know the system inside and out.
Design + Testing + Certification Under One Roof
Integrated services covering product design review, safety and performance testing at our own accredited labs, and complete regulatory certification — eliminating multi-vendor complexity.
ISO/IEC 17025 Accredited Testing Labs in India
NABL-accredited laboratories in India for electrical safety (IEC 60601), EMC, biocompatibility (ISO 10993), and performance testing — reducing turnaround time and logistics costs.
Multi-Region Regulatory Expertise
Simultaneous registrations across CDSCO, US FDA, EU MDR/CE, Saudi SFDA, and TGA Australia. One partner for global market access from a single integrated program.
Transparent Pricing & Fixed-Fee Packages
No hidden costs or hourly billing surprises. Our fixed-fee packages cover the complete scope from strategy through license issuance, with clear milestones and deliverables.
Six Steps to Your CDSCO License
A proven, structured approach that minimizes review queries and accelerates your path to the Indian medical device market.
Device Classification & Regulatory Strategy
We determine your device’s risk classification (Class A, B, C, or D) under MDR 2017 and develop a tailored regulatory strategy including applicable Indian standards, testing requirements, and the optimal submission pathway.
Documentation & Technical File Preparation
Our team prepares the complete technical documentation including device master file, risk analysis (ISO 14971), essential principles checklist, biocompatibility data, labeling, and IFU per CDSCO requirements.
Testing at ISO/IEC 17025 Accredited Labs
We conduct all required safety, performance, and biocompatibility testing at our NABL and ISO/IEC 17025 accredited laboratories in India, including IEC 60601 electrical safety, EMC, and ISO 10993 testing.
SUGAM Portal Application Submission
We submit the completed application via CDSCO’s SUGAM portal using Form MD-14 (Class A/B) or Form MD-15 (Class C/D), with all supporting documentation, test reports, and applicable government fees.
CDSCO Review & Query Resolution
We manage the entire review cycle, respond to technical queries and deficiency notices promptly, coordinate with CDSCO reviewers, and facilitate expert committee presentations when required for Class C/D devices.
License Issuance & Post-Market Compliance
Upon approval, we secure your perpetual manufacturing or import license, set up post-market surveillance and vigilance reporting systems, and manage ongoing 5-year retention fee renewals and regulatory updates.
CDSCO Registration Across All Device Sectors
NexorTest supports medical device manufacturers across every therapeutic area and technology vertical entering the Indian market.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
CDSCO Registration FAQ
Expert answers to the most common questions about medical device registration with CDSCO India.
What is CDSCO medical device registration in India?
CDSCO medical device registration is the mandatory regulatory process governed by the Central Drugs Standard Control Organisation under India’s Ministry of Health & Family Welfare. Under the Medical Device Rules (MDR) 2017, all medical devices manufactured in or imported into India must be registered with CDSCO before marketing. The process involves device classification (Class A through D), documentation preparation, testing at accredited labs, and application submission via the SUGAM portal (cdscoonline.gov.in). Registration results in a manufacturing or import license that is now perpetual, subject to 5-year retention fees.
How to apply for CDSCO registration via SUGAM portal?
To apply for CDSCO registration via the SUGAM portal (cdscoonline.gov.in): (1) Register an account on the SUGAM portal. (2) Determine your device classification (A, B, C, or D). (3) Prepare the required technical documentation and test reports. (4) Submit Form MD-14 for Class A/B devices or Form MD-15 for Class C/D devices. (5) Pay the applicable fees online. (6) Track your application status through the portal. (7) Respond to any queries raised by CDSCO reviewers. The portal supports online tracking, auto-generated compliance certificates, and digital license issuance.
What documents are required for CDSCO Class C/D registration?
CDSCO Class C/D registration via Form MD-15 requires: device master file including design and manufacturing details, risk analysis report (ISO 14971), essential principles checklist, biocompatibility test reports (ISO 10993), electrical safety reports (IEC 60601 if applicable), software validation documentation for SaMD, clinical investigation reports or clinical evidence, ISO 13485 QMS certificate, labeling and IFU, shelf-life or stability data, free sale certificate from country of origin (for imports), and authorized Indian agent documentation. All test reports must come from ISO/IEC 17025 accredited laboratories.
What is the cost of CDSCO medical device registration?
CDSCO medical device registration costs include government fees and professional consulting fees. Government application fees range from INR 5,000 for Class A devices to INR 50,000 for Class D devices. Testing costs at accredited labs vary significantly based on device type and required standards (ISO 10993, IEC 60601, etc.). Professional consulting fees depend on device complexity, classification, and scope of services. NexorTest offers transparent fixed-fee packages covering regulatory strategy, documentation, testing coordination, SUGAM portal submission, and post-market compliance support. Contact us for a free cost assessment.
What are the CDSCO device classification classes?
CDSCO classifies medical devices into four risk-based classes under MDR 2017. Class A represents low-risk devices such as tongue depressors and bandages. Class B covers low-moderate risk devices like hypodermic needles and surgical gloves. Class C includes moderate-high risk devices such as ventilators and dialysis machines. Class D encompasses the highest-risk devices including cardiac stents and implantable defibrillators. As of 2025-2026, CDSCO has reclassified 553 devices under a risk-based framework. Class A non-sterile, non-measuring devices can be self-notified, while all other classes require CDSCO review.
How long does CDSCO registration take?
CDSCO registration timelines vary by device class. Class A non-sterile, non-measuring devices can be self-notified within 1-2 weeks. Class A (sterile/measuring) and Class B devices typically take 3-6 months via Form MD-14. Class C devices generally require 6-9 months, while Class D devices may take 9-15 months via Form MD-15. Timelines depend on documentation completeness, testing requirements, and CDSCO query response cycles. NexorTest’s regulatory experts help streamline the process by ensuring complete submissions that minimize review queries.
Is BIS certification mandatory for medical devices in India?
BIS (Bureau of Indian Standards) certification is mandatory for specific categories of medical devices notified by the Indian government under compulsory registration orders. Currently, devices such as cardiac stents, condoms, surgical gloves, and certain electronic medical equipment require BIS certification in addition to CDSCO registration. BIS certification involves product testing at BIS-recognized labs, factory inspection, and grant of ISI mark license. NexorTest assists manufacturers with both CDSCO registration and BIS certification to ensure complete regulatory compliance in India.
Can NexorTest help with IVD and SaMD CDSCO registration?
Yes, NexorTest provides specialized CDSCO registration services for In Vitro Diagnostic (IVD) devices and Software as a Medical Device (SaMD). For IVDs, we handle classification under IVD-specific risk categories, performance evaluation studies, analytical and clinical evidence compilation, and SUGAM portal submissions. For SaMD, we manage software lifecycle documentation per IEC 62304, cybersecurity risk assessments, clinical evidence for AI/ML-based devices, and regulatory strategy aligned with India’s evolving digital health framework. Our team has extensive experience navigating CDSCO’s review processes for both IVD and SaMD categories.
Ready to Enter the Indian Medical Device Market?
Get a free CDSCO regulatory assessment from India’s leading medical device registration consultants. Our experts will map your fastest path to market.
Accreditations & Certifications
Accredited Labs
QMS Certified
National Accreditation
Bureau of Indian Standards
Recognised Consultant
Expand Beyond India with Multi-Market Access
Leverage NexorTest's global regulatory network to register your medical device in 40+ markets from a single integrated program.
US FDA 510(k)
EU MDR CE Marking
EU IVDR
UK UKCA / MHRA
Saudi SFDA
UAE MoHAP
TGA Australia