Medical Devices Regulatory Support in India


India is one of the top global medical device markets with a significant contribution from its device imports. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The CDSCO is headed by the Drug Controller General of India (DCGI), and the approval authority is shared between the Central Licensing Authority (CLA) and the State Licensing Authority (SLA). The CDSCO is also responsible for medical device registration in India.

Regulatory Authority: Central Drug Standard Control Organization (CDSCO)

Regulation:  Medical Device Rules, 2017

Regulatory Pathway:  Device Listing or Registration

Authorized Representative:  Indian Authorized Agent (IAA) required for both notified and non-notified devices

QMS Requirement:  Schedule 5 of MDR 2017/ISO 13485:2016

Assessment of Technical Data:  CDSCO or notified bodies accredited by the CDSCO

Validity of License: Unlimited

Labeling Requirements:  Chapter VI of MDR 17, Legal Metrology Act

Submission Format: Online

Language: English

The Indian Medical Device registration processes are dynamic and are being made tougher day by day. There are thirty-seven (37) categories of devices that are currently notified and regulated by the CDSCO in India. More device categories are being brought into the purview of the CDSCO regulation. The Regulatory landscape in India for medical devices is depicted as below:

Medical Device Classification

Separate classification systems exist for Medical Devices IVDs. Each of these categories is divided into four (04) classes based on the extent of risk associated with these devices. Medical device classification in India is explained in the following table:

Device Class



Low Risk


Low Moderate Risk


Moderate – High Risk


High Risk


Medical Device Registration  

Indian Authorized Agent (IAA)

Foreign manufacturers should appoint an Indian Authorized Agent (IAA) to market devices in India, for which the IAA shall possess an active wholesale drug license in the 20B & 21B application forms. Foreign manufacturers may also appoint their distributors or importers as the IAA. However, having an independent IAA would provide the flexibility to appoint multiple distributors in India with no commercial interest.

All the applications for both notified and non-notified devices must be submitted through an online portal called SUGAM as the CDSCO manages the applications through the same portal.

Non-Notified Devices:  The devices not included in the list of the notified devices are not regulated in India. However, these devices shall be listed in the CDSCO portal. Foreign manufacturers shall have an IAA based in India to market these devices.

Notified Devices:  There are thirty-seven (37) categories of devices listed in the notified list regulated by the CDSCO and requiring prior approval for marketing them in India. There are different application forms, and the documentation requirements vary with the application form submitted to the CDSCO.

The choice of application varies based on the home country approval, availability of the Free Sale Certificate (FSC), nature of the applicant, operations, and type of the device. After a detailed evaluation of applications, the CDSCO issues licenses for either testing, importing, or manufacturing devices.

Intended Operation

Indian Manufacturer
(Own Site)

Indian Manufacturer (Other’s Site)

Foreign Manufacturer

Device manufacturing for distribution or sales

Manufacturing license

Loan license


Device manufacturing/importation for testing purposes

Test license

Test license

Test license

Device importation for distribution in India (with reference country approval)



Import license without SEC technical assessment


Process flow 


Product Maintenance & Compliance

Sl. No




Validity for import registration

Three (03) years from the date of registration


Renewal of import registration certificate

Nine (09) months before the expiry of the existing certificate


Validity for import license

Three (03) years (till the registration certificate is valid)


Renewal of import license

Minimum three (03) months before the expiry of the import license (application for import license should be submitted along with the application for renewal with the importer)


Type of Device 


Device Class

QMS Audit 

Regulatory Pathway 


Final Outcome 

Non-Notified Device 




Listing of devices in the SUGAM portal 


Listing in database

Notified Device 

Low Risk 

Schedule 5 of MDR 2017 or 

ISO 13485:2016 certification 

Device Registration 


Test/Manufacture /Loan/Import License 

Low-Moderate Risk 


Moderate-High Risk 


High Risk 


Freyr Expertise

  • Regulatory Intelligence and Due-diligence Services in India
  • Medical Device Classification India and Grouping Strategy
  • Indian Authorized Agent (IAA) Representation
  • CDSCO SUGAM Account Creation and Account Management
  • Test License for Medical Devices and IVDs
  • Medical Device Import License India
  • Manufacturing License for Regulated Medical Devices and IVDs
  • Loan License for Regulated Medical Devices and IVDs
  • Listing of Non-regulated Medical Devices
  • Manufacturing Site Registration
  • Compilation Services for Device Documents and Device Master File (DMF)
  • Liaison with the CDSCO, the Central, and the State Licensing Authorities
  • In-country Testing Services
  • Post-market Surveillance
  • Atomic Energy Regulatory Board (AERB) Approval for Radiation Diagnostic Devices


Level 4, Building No. H-08,
Phoenix SEZ, HITEC City 2, Gachibowli,
Hyderabad – 500081, India


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