Medical Devices Regulatory Support in India

Overview

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	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, 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	NA
Device manufacturing/importation for testing purposes	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 the expiry of the import license (application for import license should be submitted along with the application for renewal with the 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 the SUGAM portal	Yes	Listing in database
Notified Device	Low Risk	A	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