How to Register AI Driven Medical Devices on CDSCO?

Do you know that medical tools and apps using Artificial Intelligence (AI) need approval before they can be used in India? If your software helps with diagnosis, monitoring, or treatment, it is called an AI-driven medical device. In India, these devices should be registered with CDSCO, the authority that checks if medical products are safe and work properly. 

What are AI Driven Medical Devices?

AI-driven medical devices are medical tools or software that use artificial intelligence (AI) to help doctors and patients in diagnosing, monitoring, or treating health conditions. Simply, you can understand it as a devices that use smart algorithms to analyze data, predict outcomes, or support medical decisions. They can be physical devices like imaging machines with AI features, or software-based tools like apps that detect disease from X-rays in health records. If these AI tools are made for medical purposes, they are regulated by the CDSCO in India as AI-driven medical Devices under the Medical Device Rules (MDR), 2017. 

Are AI Driven Medical Devices Regulated in India?

Yes, AI-driven medical Devices are regulated in India by the Central Drugs Standard Control Organization under the Medical Device Rules (MDR) 2017. 

• If the AI tool is used for a medical purpose like diagnosis, monitoring, prediction, or treatment, it is treatment as a medical device.
• It can be a physical device with AI features or standalone software using AI
• CDSCO reviews and approves these devices before they can be sold or used in India.
• The AI-driven medical Devices should be classified based on their level (Class A to D)
• The device also needs to meet performance requirements. Safety and quality standards, including proper clinical validation and risk management.

When is AI Software Considered a Medical Device?

AI software is considered a medical device when it is used to diagnose, monitor, treat, or prevent a disease or health condition. If the AI software helps doctors or patients make medical decisions or gives medical advice, it is treated as a Driven Medical Device and should be registered with the CDSCO.

Who Regulates AI Driven Medical Devices in India?

AI-driven medical Devices in India are regulated by the Central Drugs Standards Control Organization. CDSCO is the national authority that checks if medical devices, including AI-based tools, are safe, effective, and meet quality standards. It works under the Ministry of Health and Family Welfare and follows the rules given in the Medical Device Rules (MDR), 2017.

How to Classify AI Driven Medical Devices Before Registration?

To register an AI-driven medical device in India, you should first classify it based on risk level. CDSCO uses four classes, Class A to Class D, depending on how critical the device is for patient health.

S.No.	Class	Risk Level	Example of an AI-Driven Medical Device
1.	Class A	Low Risk	An AI tool that reminds patients to take medicine
2.	Class B	Low to Moderate Risk	AI that tracks heart rate and alerts for unusual patterns
3.	Class C	Moderate to High Risk	AI that helps detect early signs of cancer from reports
4.	Class D	High Risk	AI used in critical care to support real-time diagnosis

What is the Process to register AI driven medical Devices Under CDSCO?

Registering an AI-driven medical Device in India involves a few important steps that should be followed as per CDSCO and the Medical Device Rules (MDR), 2017. 

Check If Your AI Software is a Medical Device – First, see if your AI tool is made for diagnosing, monitoring, or treating any health condition. If yes, it is considered an AI-driven medical device.

Determine the Risk Classification (Class A to D)

• Class A – Low Risk
• Class B – Moderate Risk
• Class C – High Risk
• Class D Very High Risk

Appoint an Authorized Indian Agent (For Imports) – If your AI devices is made outside India, appoint an Authorized Indian Agent to apply on your behalf.

Prepare All Required Documents – You have to gather all the required documents:

• Covering Letter
• Classification Justification
• Software Architecture
• Clinical Evaluation or Performance Data

Apply Online on CDSCO SUGAM Portal – Submit the application through the CDSCO’s Online SUGAM Portal using the right form:

CDSCO Forms for Indian Manufactures

S.No.	Device Class	Application Form	License Issued	Description
1.	Class A & B	Form MD-3	Form MD-5	Submitted to the state licensing authority (SLA) for low to moderate-risk devices
2.	Class C & D	Form MD-7	Form MD-9	Submitted to CDSCO HQ for moderate to high-risk devices

CDSCO Form for Importers

S.No.	Device Class	Application Form	Licensed Issued
1.	All Classes	Form MD-14	Form MD-15

Pay Government Fees – Now submit the required fee as mentioned on the portal, it is based on your device class and type (Import or Manufacture)

Get the License – In the end, if everything is in correct order and you are following our steps, then CDSCO will issue:

• A manufacturing license (Form MD-5) for Indian Makers
• An Import License (Form MD-15) for foreign products

What Documents Are Required to Register AI Driven Medical Devices?

For Indian Manufacturers (Apply using form MD 3)

• Covering letter
• Duly Filled Application Form (Form MD 3)
• Name & Address of the Manufacturer
• Contact Details
• Manufacturing Site Details
• Device Master File (DMF) – Required for Class C & D
• Plant Master File (PMF) – Required for Class C & D
• Product Description (including software type, AI algorithms used
• Software Architecture Diagram
• Intended Use & Medical Functionality
• Clinical Evaluation Report or Performance Data
• Risk Management File
• Software Development Life Cycle File
• Software Validation Reports
• Source Code Summary
• Quality Managent System Certificate (ISO 13485)
• Labels, Packaging Design, and Artwork
• Instructions for Use (IFU)/User Manual
• Declaration of Conformity to Indian Standards
• Details of Technical & Regulatory Staff
• Factory License or Site Registration Documents

For Importers (Apply using MD 14)

• Covering Letter
• Duly Filled Application form MD-14
• Name & Address of the Foriegn Manufacturers
• Name & Address of Authorized Indian Agent
• Power of Attorney/Authorization Letter
• Free Sale Certificate (FSC)
• Contact Details
• Manufacturing Site Details
• Device Master File (DMF)
• Plant Master File (PMF)
• Software Architecture & Algorithm Details
• Intended Use & Medical Purpose
• Clinical Evaluation/Performance Testing Reports
• Risk Managment File 
• Software Validation & Testing Reports
• Software Life Cycle Documents 
• CE Certificate/US FDA Clearance
• Label, Artwork, and IFU
• ISO 13485 Certificate of Manufacturing Site
• Declaration of Conformity to Indian Standards

What are the Compliance Requirements After Registration of AI Driven Medical Devices?

After you register your AI-driven medical Devices with CDSCO, you should follow certain compliance rules to ensure that the product remains safe, effective, and legally approved in India.

• Use as Per Approved Intended Use
• Correct Labeling and Instructions
• Maintain Quality Management System (QMS)
• Adverse Event Reporting 
• Version and Software Updates
• Record Keeping and Audit Readiness
• User Training & Support

How Can ELT Corporate High in AI Driven Medical Device Registration?

ELT Corporate is one of the best regulatory consultancies in India, and can help you smoothly register your AI-driven medical device with CDSCO. We will help you through classification, documentation, and complete compliance.

• Expertise in AI Medical Device Regulation
• Complete Support from classification to CDSCO approval
• Assistance in preparing DMF, PMF, and Technical documents
• Team of regulatory, technical, and legal experts
• Help with test license, clinical evaluation, and post-market compliance
• Trusted by over 2500+ satisfied clients
• Fast, transparent, and cost-effective services