The Central Drugs Standard Control Organization (CDSCO) has published the final Guidance Document on Medical Device Software (MDSW), providing a comprehensive regulatory framework for software intended for medical purposes under the Medical Devices Rules, 2017 (MDR-2017).
The guidance, released by the CDSCO’s Medical Devices and In Vitro Diagnostics (IVD) Division, aims to align India’s regulatory requirements with globally harmonized practices while supporting innovation, patient safety, product quality and timely market access for medicaldevice software.
According to the regulator, all medical devices, including software intended for medical purposes, are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, ensuring their quality, safety and performance.
A draft version of the guidance was published in October 2025 for public consultation. Following a review of stakeholder feedback in consultation with experts, CDSCO has now finalised and published the document for implementation.
The guidance outlines regulatory expectations for medical device software, including the regulatory framework, classification principles, applicable safety and performance requirements, documentation expectations, quality management considerations, and post-market obligations.
It is intended to promote a consistent understanding of regulatory requirements among manufacturers, importers, innovators and other stakeholders.
The regulator noted that software is playing an increasingly important role in healthcare, supporting a wide range of medical and administrative functions across clinical and private settings.
“The purpose of this document is to provide guidance to stakeholders (manufacturers, importers and innovators/researchers, etc.) for the submission of application to the Licensing Authority (LA) for obtaining regulatory approvals for Medical Device Software (including In-vitro Diagnostic (IVD) Medical Device Software) under the MDR-2017,” it said.
CDSCO has advised all stakeholders to refer to the guidance while submitting applications for regulatory approvals under the Medical Devices Rules, 2017.
The regulator clarified that the guidance document applies to software products that fall within the definition of a “medical device” mentioned in the Medical Devices Rules, 2017 under the Drugs and Cosmetics Act, 1940.
The guidance does not apply to software intended solely for general wellness, promoting a healthy lifestyle, or tracking body parameters for fitness purposes, provided it is not intended for any medical purpose.
CDSCO noted that all applications regarding manufacturing or import, clinical investigations, and registration for sale and distribution of medical devices must be submitted through its designated online portals.
Applications for Test Licences must be filed through the National Single Window System (NSWS) portal, while applications for commercial permissions, manufacturing or import licences, and registration for sale and distribution must be submitted through the CDSCO Online System for Medical Devices (MD Online Portal).
Refer the guidance here.
