How to Register Software as a Medical Device (SAMD)?

Many apps today help with health tracking or medical advice. But if a software is made to diagnose, monitor, or treat a disease, it is called Software as a Medical Device (SaMD). In India, such software should be registered with CDSCO, the government body that checks if medical products are safe and work properly. Not all health-related apps need registration; only those that have a medical purpose, like detecting a condition or guiding treatment, come under SaMD and should follow proper rules. You can check this content to know all the details regarding the registration procedure.

What is Software as a Medical Device (SaMD)?

Software as a Medical Device (SaMD) refers to any software that is developed to perform a medical function, such as diagnosing, monitoring, or treating disease, without being part of a physical medical device. In simple words, it is a standalone software that can diagnose, monitor, treat, or prevent disease and is used independently on devices like computers, tablets, and smartphones. According to the Central Drugs Standard Control Organization (CDSCO) in India, SaMD is regulated as a medical device if its intended use involves medical purposes such as:

• Diagnosing a Medical Condition
• Monitoring Patient Health
• Suggesting Treatments

When is Software Considered a Medical Device in India?

Software is considered a medical device in India when it is specifically designed to perform medical functions such as diagnosis, prevention, monitoring, treatment, or management of diseases without being part of any physical hardware. As per the Medical Device Rule (MDR), 2017 issued by CDSCO, software is classified as software as a Medical Device (SaMD) if its intended use is related to:

• Diagnosing health conditions
• Monitoring physiological data
• Supporting Clinical Decisions
• Managing or preventing diseases

Which Authority Regulates Software as a Medical Device in India?

In India, software as a Medical Device (SaMD) is regulated by the Central Drugs Standards Control Organization (CDSCO). CDSCO is the national regulatory authority responsible for overseeing the safety, quality, and effectiveness of medical devices, including SaMD. It works under the Ministry of Health and Family Welfare and follows the Medical Device Rules (MDR), 2017 to decide how software as a Medical Device should be classified, registered, and monitored. Before you can sell or distribute any software as a medical device in India, you must:

• Check its classification (Class A to D)
• Apply the CDSCO
• Get the required license or registration certificate

How to Classify Software as a Medical Device (SaMD) Before Registration?

Before registering software as a medical device (SaMD) in India, it is important to classify the software based on its intended use and risk level. This classification helps determine the type of regulatory process you need to follow under the CDSCO.

SaMD is classified into four risk-based categories:

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

What is The Process to Register Software as a Medical Device in India?

The process to register software as a medical device (SaMD) in India is managed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules (MDR), 2017. 

1. Check if your Software Qualifies as a Medical Device – In the first step, you have to check if your software meets the definition of software as a medical device, that is, it performs a medical function like diagnosing, monitoring, or treating a health condition without being part of a hardware device.
2. Determine the Risk Classification – Classify your SaMD into one of the four categories based on its risk level:

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

Note – Class A and B SaMD are generally regulated by the State Licensing Authorities (SLA). Class C & D SaMD are handled by the CDSCO headquarter (Delhi HQ) due to their higher risk.

3. Appoint Authorized Indian Agent (For Manufacturers) – If the software is developed outside India, you should appoint an Indian authorised agent who will apply on your behalf.
4. Prepare Required Documents – You have to prepare all the needed documents that include:

• Covering Letter
• Device Master
• Power of Attorney

5. Submit Application on CDSCO Online Portal – Register on the CDSCO SUGAM Portal, upload all documents, and submit the application in the correct form depending on your case.

• Form MD 3 – For Indian manufacturers
• Form MD 14 – For Foreign manufacturers (Import License)

6. Pay Government Fee – Now you are required to pay the fee based on the classification and type of application.
7. Technical Review by CDSCO – CDSCO will review your application, verify the documents, and may ask for clarification or additional information. For higher risk software (Class C & D), a more detailed evaluation or audit might be required. 
8. Grant of License – In the end, if everything is in correct order, you will get your license.

• Manufacturing License
• Import License

Which Documents Are Required to Register Software as a Medical Device (SaMD)?

For Manufacturing SaMD in India

• Covering Letter
• Duly Filled Application Form
• Form MD 3 
• Form MD 14
• Name and Address of the Company
• Contact Information
• Manufacturing Site Details
• Software Description and Architecture
• Intended Use
• Medical Functionality
• Clinical Evaluation Data
• Performance Studies
• Software Validation Reports
• Risk Management File as per ISO 14971
• Software Life Cycle Process (Per IEC 623904)
• Source Code Summary 
• Instruction for Use IFU/User Manual 
• Label Sample and Artwork
• Undertaking of Conformity to Indian Standards
• Quality Management System (QMS) Certificate – ISO 13485
• Technical Staff Details
• Factory License/Site Plan

For Importing SaMD into India

• Covering Letter
• Duly Filled Application Form (Form MD-14)
• Name and Address of the Forein Manufacturer
• Details of Authroized Indian Agent 
• Agreement of Power of Attorney 
• Free Sale Certificate
• Contact Details
• Device Master File (DMF)
• Plant Master File (PMF)
• Software Validation Reports
• Risk Management (ISO 14971)
• Software Life Cycle Details 
• Source Code Summary 
• Instruction for Use (IFU)/User Manual
• Label and Packaging Artwork
• ISO 13485 Certificate

Compliance Requirements After SaMD Registration Check

S.No.	Compliance Area	What You Need To Do
1.	Intended Use	Use software only as approved during registration
2.	Quality Management System (QMS)	Maintain an ISO 13485-certified QMS for all processes
3.	Labeling	Keep digital and printed labels accurate and up to date
4.	Adverse Event Reporting	Report any issues or risks to CDSCO through MvPi
5.	License Validity	Be ready for audits by CDSCO, keep records and logs available
6.	User Training & Support	Ensure users are trained and supported post-launch

How Can ELT Corporate Help You with Registration Software as a Medical Device (SaMD)?

ELT corporate, one of the best regulatory consultancies in India, can help you complete the process of registering software as a medical device (SaMD) under CDSCO by handling classification, documentation, application filing, and compliance support. 

• Expertise in the CDSCO SaMD registration process
• End-to-end support from classification to license approval
• Strong team of legal, technical, and medical device experts
• Trusted by 2500+ satisfied clients
• Fast, transparent, and affordable services