Step-by-Step Guide to Register a Medical Device in India

The Indian medical device market is rapidly expanding, driven by advancements in technology and increasing healthcare demand. If you are a manufacturer or distributor planning to enter India, understanding the regulatory requirements is crucial. The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority responsible for medical device registration in India. Here’s a detailed guide to help you navigate the registration process.

1. Regulatory Body: CDSCO

All medical device registrations in India are managed by the CDSCO, which has a dedicated online portal called SUGAM for submitting applications. The portal facilitates online submission for import licenses, manufacturing licenses, and registration certificates.

The CDSCO operates under the Ministry of Health and Family Welfare and coordinates with both Central Licensing Authority (CLA) and State Licensing Authorities (SLA) depending on the type of device.

2. Device Classification

India follows a risk-based classification system for medical devices, as outlined in the Medical Devices Rules, 2017 (MDR 2017): The classification determines the regulatory pathway, licensing authority, and documentation required for registration.

3. Regulatory Pathway

The registration process in India typically involves the following steps:

Step 1: Appoint an Indian Authorized Representative (AR)

Foreign manufacturers must appoint an Indian Authorized Agent, who acts as the primary liaison with CDSCO. The AR is responsible for all regulatory communication and application submissions in India.

Step 2: Prepare a Technical Dossier

The technical dossier provides detailed information about the device, including:

Step 3: Implement a Quality Management System (QMS)

Manufacturers are required to maintain a Quality Management System that complies with regulatory standards. A robust QMS ensures that the device is consistently produced and controlled according to quality standards.

Step 4: Obtain Free Sale Certificate (For Import Applications)

Foreign manufacturers must submit a Free Sale Certificate or equivalent regulatory approval from their country of origin. This demonstrates that the device is legally marketed in the home country.

Step 5: Register on the SUGAM Portal

All applications for device registration, import, and manufacturing licenses must be submitted online through the SUGAM portal. Steps include:

Create a user account on SUGAM
Upload the application, technical dossier, and supporting documents

Step 6: Submit the Application

Submit the completed application for the appropriate license

Step 7: CDSCO Review and Approval

The timeline for regulatory review depends on the device class

Step 8: Inspection (If required)

Class A: Inspection may occur within 120 days after license issuance
Class B: Audit of manufacturing site by Notified Body within 90 days
Class C & D: Inspection by CLA within 60 days

Conclusion

Registering a medical device in India is a structured process involving classification, technical documentation, quality management, online submission via SUGAM, and approval by CDSCO. Understanding each step is essential to ensure compliance, reduce delays, and successfully bring your device to the Indian market.

With proper planning, appointment of an Indian Authorized Representative, and adherence to the MDR 2017, manufacturers can navigate the regulatory pathway efficiently and gain timely approval for marketing or importing medical devices in India.

CDSCO Forms Under MDR 2017

Form No	Description
Form MD1	Application for grant of certificate of registration of a notified body
Form MD3	Application for grant of license to manufacture for sale or for distribution for Class A or Class B medical device
Form MD4	Application for grant of loan license to manufacture for sale or for distribution of Class A or Class B medical device
Form MD5	Licence to manufacture for sale or for distribution of Class A or Class B Medical Device
Form MD6	Loan Licence to manufacture for sale or for distribution of Class A or Class B Medical Device
Form MD7	Application for grant of license to manufacture for sale or for distribution of Class C or Class D medical devices
Form MD8	Application for grant of loan license to manufacture for sale or for distribution of Class C or Class D medical device
Form MD9	Licence to manufacture for sale or for distribution of Class C or Class D Medical Device
Form MD10	Loan Licence to manufacture for sale or for distribution of Class C or Class D Medical Device
Form MD11	Form in which the audit or inspection book shall be maintained
Form MD12	Application for license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration, or training
Form MD13	Licence to manufacture Medical Device for the purpose of clinical investigations or test or evaluation or demonstration or training
Form MD14	Application for issue of import license to import medical device
Form MD15	Licence to import Medical Device
Form MD16	Application for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training
Form MD17	Licence to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training
Form MD18	Application for license to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients
Form MD19	Licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients
Form MD20	Application for permission to import small quantity of medical devices for personal use
Form MD21	Permission to import small quantity of medical devices for personal use
Form MD22	Application for grant of permission to conduct clinical investigation of an Investigational Medical Device
Form MD23	Permission to conduct clinical investigation of an Investigational Medical Device
Form MD24	Application for grant of permission to conduct clinical performance evaluation of New In-Vitro Diagnostic Medical Device
Form MD25	Permission to conduct clinical performance evaluation of New In-Vitro Diagnostic Medical Device
Form MD26	Application for grant of permission to import/manufacture for sale or for distribution of medical device which does not have a predicate medical device
Form MD27	Permission to import/manufacture for sale or for distribution of medical device which does not have a predicate medical device
Form MD28	Application for grant of permission to import or manufacture for sale or for distribution of a New In-Vitro Diagnostic Medical Device
Form MD29	Permission to import or manufacture New In-Vitro Diagnostic Medical Device
Form MD30	Memorandum to Central Medical Device Testing Laboratory