Food and Drugs Administration, (FDA) Haryana, India. |
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Last Updated on July 23, 2026 by The Health Master
Medical Device Software
The Central Drugs Standard Control Organization (CDSCO), has released the final guidance on the Medical Device Software (MDSW).
This final document updates the initial draft that was floated in October 2025 and finalizes the regulations as part of the Medical Devices Rules (MDR), 2017.
Download Guidance Document for Medical Device Software
For all those who develop healthcare and medical software or import medical devices into India, this final document from the CDSCO will provide clarity on the risk classifications for software, software that uses artificial intelligence, the quality management systems that would need to be utilized, and the licensing of the software as it undergoes its testing phase.
Key Highlights
The primary goal of the CDSCO is to align the regulations for medical device software with the best practices and regulations that have been established internationally in relation to such medical software.
By releasing this final document, Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), stated that the regulatory authority will be able to provide an overview of what is to be submitted by the manufacturers of medical device software to speed up the process of gaining regulatory approval while ensuring the safety of the patients and the quality of the medical devices being manufactured.
This document will apply to the manufacturers, importers, innovators, and researchers of medical device software who plan to submit an application for regulatory approval for their product.
Medical Device Software (MDSW)
Medical Device Software (MDSW) is the term that will be used for software applications that have been classified as such and which meet the criteria as defined in the new regulation.
The initial draft classified software as either Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD). The final document consolidates these into the term Medical Device Software (MDSW).
Included Technologies
Any software that falls into any of the following categories will be classified as MDSW:
Artificial intelligence and Internet of Things (IoT) driven platforms that connect to physical medical devices.
These platforms are used for monitoring patients with chronic conditions such as diabetes or cardiovascular diseases.
Digital therapeutic (DTx) software that is used as a remote treatment for the prevention of the onset or progression of diseases such as type 2 diabetes or hypertension.
In-Vitro Diagnostic (IVD) software that is used to analyse samples of human body fluids.
Excluded Technologies
Software that falls outside of the following categories would not be classified as Medical Device Software (MDSW):
Software that is used for the tracking of physical fitness or other body parameters without any medical purpose.
Software that is used in the management and manufacturing of medical devices, such as enterprise resource planning (ERP) software or software that manages the complaints regarding medical devices.
Such software is used within manufacturing facilities.
Core Requirements and Technical Specifications
The CDSCO has defined several terms that will be used throughout the regulatory and manufacturing documentation of MDSW:
- Software Bill of Materials (SBOM)
- Real World Data (RWD)
- Real-World Evidence (RWE)
- Product Lifecycle Management
Risk-Based Classification of Medical Device Software
The risk-based classification of MDSW will be referenced with the list that is published by the CDSCO.
If the specific software product that is to be regulated does not have a classification within this list, then an online application will need to be submitted to the CDSCO MD Portal to obtain such a classification for the software.
Quality Management System (QMS) Requirements
Manufacturers of MDSW will have to implement a quality management system (QMS) that ensures that the software is manufactured in a manner that minimizes the risk of any defects or failures of the software to perform in its intended manner.
The standards that will be referenced include the following:
- IS/IEC 62304: Medical device software – Software lifecycle processes
- IS/ISO 14971: Medical devices – Application of risk management to medical devices
- IS/IEC 82304-1: Health software – Part 1: General requirements for product safety
Cybersecurity Requirements
The software will have to be secured in relation to the physical devices that are created by the manufacturers.
This will include the security of the third-party and open-source software that is included with the software platform.
Software bills of materials will have to be maintained for each product and be updated periodically.
Validation of Clinical Workflows in India
The documentation for medical device software has to prove that the usability of the software was tested in real clinical environments in India.
These conditions will have to be accounted for in the documentation, including but not limited to the following:
- Documentation regarding whether the software can be accessed by local languages
- The training level required for the individuals that will operate the medical devices
- The level of the infrastructure that is required to operate the devices and software in India
Essential Risk Management Domains
The risk management documentation for each product will have to include information regarding the following domains:
| Risk Domain | Regulatory Expectation |
| Hazard Identification | Systematic evaluation of operational and clinical risks. |
| Cybersecurity | Safeguards against unauthorized access, data leaks, and code vulnerabilities. |
| AI Bias | Algorithm evaluation across diverse demographics to prevent algorithmic bias. |
| Misuse Scenarios | Assessment of potential operator error or off-label user behavior. |
| Residual Risk Analysis | Evaluation of overall safety after implementing design controls and mitigations. |
Additional information for Medical Devices
For additional information for Medical Devices, click below:
Medical Devices Rule 2017
To download Medical Devices Rule 2017, click below
Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
Medical Device Alert
Medical Device Alert, click the below link
Medical Device Notifications
For various notifications of medical devices, click the below link:
Notifications – Medical Devices
For informative videos on Medical Devices, click on the below YouTube icon:
