India is one of the world's largest and fastest-growing medical device markets. The Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare, regulates medical devices in India under the Medical Devices Rules, 2017 — commonly referred to by their key provision, Rule 126. Any foreign manufacturer wishing to import and sell medical devices in India must navigate CDSCO's registration and import licensing framework.

Since 2017, India has progressively tightened its medical device regulatory framework, moving from a largely unregulated market to a structured risk-based classification system with mandatory registration. The framework is broadly harmonised with the Global Harmonization Task Force (GHTF) model but has India-specific requirements that make direct compliance with CE or FDA alone insufficient for market entry.

Regulatory authority: The Central Licensing Authority (CLA) at CDSCO, New Delhi handles import licences for medical devices. The Drug Controller General of India (DCGI) is the apex regulatory authority for medical devices in India.

Medical Device Classification in India

India uses a four-class risk-based classification system for medical devices, similar to the EU MDR framework:

Class A
Low Risk
Non-invasive devices, general hospital supplies. Examples: bandages, tongue depressors, examination gloves, non-sterile wound dressings. Registration required but process is streamlined.
Class B
Low-Moderate Risk
Non-invasive devices that contact body openings, devices for channelling or storing blood. Examples: hearing aids, contact lenses, ultrasound gel, infusion sets.
Class C
Moderate-High Risk
Long-term implantable devices, active therapeutic devices. Examples: orthopaedic implants, dialysis equipment, ventilators, blood glucose monitors.
Class D
High Risk
Implantable devices that contact the central nervous system or cardiovascular system. Examples: pacemakers, heart valves, cochlear implants, active implantable devices.

Which Devices Require CDSCO Registration?

India has been progressively expanding the list of devices requiring mandatory CDSCO registration. As of 2025, all medical devices — regardless of class — require either registration or import licence from CDSCO before they can be imported and sold in India.

Device CategoryClassRegulatory Requirement
Surgical instruments (reusable)A/BRegistration
Diagnostic imaging equipmentB/CImport licence
In-vitro diagnostic devicesA–DRegistration / Import licence
Orthopaedic implantsC/DImport licence + clinical data
Cardiac devicesDImport licence + clinical data
Hospital furniture & bedsARegistration
Dental devicesA/B/CRegistration / Import licence

The CDSCO Import Licence Process — Rule 126

  1. Device Classification Determination

    Determine the correct classification of your device under India's Medical Devices Rules, 2017. Classification determines the regulatory pathway, documentation requirements, and whether clinical data from India is required.

  2. Appointment of Indian Authorised Representative

    Foreign manufacturers must appoint an Indian Authorised Representative (IAR) who holds a valid wholesale drug licence. The IAR applies for and holds the import licence on behalf of the foreign manufacturer.

  3. Technical Documentation Preparation

    Prepare the technical dossier including device description, classification justification, design and manufacturing information, risk management documentation, clinical evidence, performance data, labelling, and post-market surveillance plan.

  4. Application on SUGAM Portal

    Application is filed on CDSCO's SUGAM online portal. All documents are uploaded digitally. Application fees vary by device class and number of models.

  5. CDSCO Technical Review

    CDSCO's technical committee reviews the application. Additional information, clarifications, or expert committee referral may be required — particularly for Class C and D devices. For novel devices or high-risk devices, clinical investigation data from Indian patients may be required.

  6. Grant of Import Licence

    Upon satisfactory review, CDSCO issues the import licence under Rule 126. The licence specifies the approved device, models, and conditions of import. Licences must be renewed periodically and updated when device modifications are made.

Clinical Data Requirements

For Class C and Class D devices — and for certain Class B devices with higher risk profiles — CDSCO requires clinical data demonstrating the device's safety and performance. India has a preference for clinical data generated in Indian patient populations, which is a significant consideration for foreign manufacturers who may only have clinical data from European or US trials.

In practice, CDSCO accepts clinical data from well-conducted international trials if the patient population is representative and the clinical outcomes are relevant to Indian conditions. However, for certain device categories — particularly implants and cardiovascular devices — CDSCO may require additional Indian clinical data or a bridging study.

CDSCO vs FDA vs CE — Key Differences

ParameterCDSCO (India)FDA (USA)CE (Europe)
Regulatory BodyCDSCO / DCGIFDA CDRHNotified Bodies
Indian Clinical DataMay be requiredNot requiredNot required
Local RepresentativeMandatory (IAR)Not requiredRequired (EC Rep)
Self-CertificationNot permittedSome Class ISome Class I
Online PortalSUGAMeSTAREUDAMED

Expert CDSCO regulatory support

ICS's medical device team — led by Dr. Ruchi Kumari with CDSCO and AIIMS background — provides end-to-end CDSCO registration support: device classification, IAR coordination, technical dossier preparation, SUGAM portal filing, and clinical data strategy for Indian market entry.

Get CDSCO Advisory
CDSCO India Medical Device Registration Rule 126 Import Licence India Medical Device Classification DCGI India Healthcare India