Regulatory Support for
Medical Devices in India
End-to-end CDSCO registration and compliance expertise for medical device and IVD manufacturers, distributors, and importers seeking access to India’s fast-growing medical device market.
🔍 CDSCO Regulatory Pathways
Low & Low-Moderate Risk
Moderate-High & High Risk
Foreign Manufacturers
Domestic Facilities
CDSCO Medical Device Registration
All notified medical devices sold in India must be registered or licensed with the CDSCO, regardless of risk classification.
✅ Class B
✅ Class C
✅ Class D
✅ IVD Devices
⚠️ Key Requirement: Since October 2023, every Class C and Class D device — including previously non-notified categories — must hold a valid CDSCO licence before it can be sold or imported. Foreign manufacturers must appoint an Indian Authorized Agent (IAA) and cannot register directly.
What Is CDSCO Medical Device Registration?
The Central Drugs Standard Control Organisation (CDSCO), operating under India’s Ministry of Health and Family Welfare, regulates and monitors the manufacture, import, sale, and distribution of medical devices and IVDs under the Medical Device Rules, 2017 (MDR 2017). Every manufacturer, distributor, and importer must comply before selling in the Indian market.
RABT Global provides comprehensive regulatory support to navigate the CDSCO registration and licensing process — from device classification and Indian Authorized Agent (IAA) representation through import/manufacturing licensing, facility compliance, and post-market surveillance.
Our specialists guide you through every requirement under MDR 2017 and the SUGAM online portal, ensuring your device reaches the Indian market efficiently and compliantly.
Overview of the CDSCO Medical Device Registration Process
A structured pathway to Indian market entry for medical and IVD devices — from classification through post-market compliance.
Determine Device Classification
Classify the device under Schedule I of MDR 2017 into Class A (low risk), B (low-moderate), C (moderate-high), or D (high risk) using the CDSCO classification database or device search on the SUGAM portal.
Class A / B / C / D
Appoint an Indian Authorized Agent (IAA)
Foreign manufacturers cannot register directly with CDSCO. An IAA holding a valid wholesale drug or medical device licence must represent the manufacturer before the regulator.
Mandatory for Foreign Manufacturers
Implement a Quality Management System
ISO 13485 certification is required for most Class B, C, and D devices and supports both import and manufacturing licence applications.
ISO 13485
Conduct Clinical Investigation (if required)
Class C and D devices generally require clinical evaluation reports or investigation data under MDR 2017 and the New Drugs and Clinical Trials Rules, 2019, unless substantial equivalence is demonstrated.
Class C / D
Prepare & Submit Application via SUGAM
Application type depends on classification and route (import vs. manufacturing) — Forms MD-3, MD-5, MD-7, MD-9, MD-14, or MD-15. RABT Global prepares submission-ready dossiers including the Device Master File (DMF) and Plant Master File (PMF).
MD-3 / MD-9 / MD-14 / MD-15
Facility & Site Compliance
Manufacturing sites must meet MDR 2017 facility and quality requirements; CDSCO may inspect manufacturing and testing facilities as part of licence evaluation for higher-risk devices.
Class C / D Facilities
Receive Registration or Licence
CDSCO issues the registration certificate or manufacturing/import licence once the application and supporting documentation are found compliant.
Registration / Licence Granted
Comply with Labelling & GMP Requirements
Devices must carry compliant labelling (device name, manufacturer details, intended use, warnings) and manufacturers must maintain Good Manufacturing Practices throughout the product lifecycle.
Labelling / GMP
Post-Market Surveillance
Manufacturers must report adverse events to CDSCO, maintain vigilance systems, and implement corrective measures — licences remain valid subject to ongoing compliance and renewal where applicable.
Ongoing Obligation
Import Licence vs. Manufacturing Licence — Which Pathway Applies?
Understanding the right registration route is critical to a successful CDSCO regulatory strategy.
Import Licence — Form MD-14 / MD-15
For foreign manufacturers placing devices on the Indian market
Requires appointment of a mandatory Indian Authorized Agent (IAA)
Application filed through the CDSCO SUGAM portal
Supporting documents include Free Sale Certificate, Plant Master File, and Device Master File
Class C & D imports require clinical evaluation data
Application fees apply; processing timelines vary by device class
Manufacturing Licence — Domestic Facilities
Required for devices manufactured within India
ISO 13485-aligned Quality Management System mandatory
State and Central Licensing Authorities involved depending on device class
Facility inspection required for higher-risk (Class C/D) manufacturing sites
Test licence may be needed prior to manufacturing for clinical or market samples
Manufacturing site registration and listing maintained on SUGAM
CDSCO Regulatory Services We Provide
Comprehensive support across every stage of India’s medical device regulatory lifecycle.
Classification Strategy
Device classification and grouping strategy under MDR 2017.
IAA Representation
Indian Authorized Agent (IAA) representation for foreign manufacturers.
Test Licensing
Test licences for medical devices and IVDs.
Import Licensing
Import licences for regulated medical devices and IVDs (MD-14/MD-15).
Manufacturing Licensing
Manufacturing licences for regulated medical devices and IVDs.
Device Listing
Listing support for non-regulated medical devices.
Site Registration
Manufacturing site registration on the SUGAM portal.
Documentation
Compilation of device documentation and the Device Master File (DMF).
Regulatory Liaison
Liaison with CDSCO, Central, and State Licensing Authorities.
Post-Market Surveillance
Post-market surveillance, vigilance reporting, and change management.