Medical Devices Regulatory Intelligence in India

Overview

India is one of the top global Medical Device markets with its major contribution from device imports. Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. 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). 

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 CDSCO 

Validity of License: Unlimited 

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

Submission Format: Online 

Language: English 

Indian Medical Device regulations are dynamic and are being made more stringent day by day. There are 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 in the coming years. The Regulatory landscape in India is depicted as below: 

Medical Device Classification

Separate classification systems exist for Medical Devices and Invitro Diagnostic Devices (IVD). Each of these categories are classified into 4 classes based on the extent of risk associated with these devices. 

Device Class

Risk

A

Low Risk

B

Low Moderate Risk

C

Moderate – High Risk

D

High Risk

 

Medical Device Registration 

Indian Authorized Agent (IAA)

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

All the applications for both notified and non-notified devices must be submitted through an online portal called SUGAM, and 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 37 categories of devices listed in the notified list, which are regulated by the CDSCO and require prior approval for marketing them in India. There are different types of application forms and the documentation requirements that vary with the application form submitted to the CDSCO. 

The choice of application varies based on the home country approval, availability of Free Sale Certificate (FSC), nature of applicant, operations and type of the device. After 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

NA

Device manufacturing/importation for testing purpose

Test license

Test license

Test license

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

NA

NA

Import license without SEC technical assessment

 

Process flow 

 

Product Maintenance & Compliance

Sl. No

Application

Validity

01

Validity for import registration

Three (03) years from the date of registration

02

Renewal of import registration certificate

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

03

Validity for import license

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

04

Renewal of import license

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

Summary

Type of Device 

Risk 

Device Class

QMS Audit 

Regulatory Pathway 

IAA 

Final Outcome 

Non-Notified Device 

NA 

NA 

NA 

Listing of devices in SUGAM portal 

Yes 

Listing in database

Notified Device 

Low Risk 

Schedule 5 of MDR 2017 or 

ISO 13485:2016 certification 

Device Registration 

Yes 

Test/Manufacture /Loan/Import License 

Low-Moderate Risk 

B

Moderate-High Risk 

C

High Risk 

D

Freyr Expertise

  • Regulatory Intelligence and Due-Diligence Services in India 
  • Medical Device Classification and Grouping Strategy 
  • Indian Authorized Agent (IAA) Representation 
  • SUGAM Account Creation and Account Management 
  • Test License for Medical Devices and IVDs 
  • Import License for Regulated Medical Devices and IVDs 
  • 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, Central and State Licensing Authorities 
  • In-country Testing Services 
  • Post-market Surveillance 
  • AERB Approval for Radiation Diagnostic Devices

Location

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

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