India CDSCO Finalizes Guidance on Medical Device Software

The Central Drugs Standard Control Organization (CDSCO), India’s medical device and in vitro diagnostic (IVD) market regulator, has issued final guidance (PDF) on registration and market access requirements for devices qualifying as medical device software (MDSW). As anticipated by industry stakeholders based on the draft version released in 2025, the final guidance aligns India closely with other medical device and IVD software markets in terms of MDSW regulatory approaches. 

Below, Emergo by UL provides some key elements of the final guidance; manufacturers of MDSW devices seeking market access in India should review the entire guidance for registration and compliance purposes.

Guidance scope: What qualifies as medical device software in India?

Medical device and IVD device software (MDSW) as defined by the CDSCO is any software intended for a medical purpose, including software as a medical device (SaMD), software in a medical device (SiMD), medical software enabled by artificial intelligence (AI) and some mobile apps. 

The scope of the guidance does not cover products that do not serve a medical purpose, such as quality system or enterprise resource planning software, general wellness apps or data management software. Intended use of devices plays a key role in determining whether they meet MDSW criteria, as well as CDSCO registration pathways and risk classifications, according to the guidance.

MDSW intended use statements should clearly cover software’s medical purpose, targeted disease or condition, target patient populations, workflows and platforms. For IVD MDSW, intended use statements should also include elements such as analytes and types of samples for analysis, intended diagnostic levels and types of results – quantitative, semi-quantitative or qualitative.

Risk-based classification of MDSW

MDSW products are subject to the four-tier risk-based device classification system established by India’s Medical Device Rules, 2017: Class A (lowest risk), Class B, Class C and Class D (highest risk). Software that drives or affects related hardware of a medical or IVD device calls under the same classification as that hardware; standalone MDSW is classified according to factors including state of target healthcare situation/condition and the significance of data provided by the software for a healthcare decision.

CDSCO regulatory pathways for medical device and IVD MDSW

The final guidance from CDSCO establishes distinct market access pathways for medical devices and IVDs, respectively, that qualify as MDSW in India.

• Medical device MDSW regulatory pathways include requirements for test licensing, clinical investigation, manufacturing licenses for commercialization in India, and import licensing. (See Fig. 1 in CDSCO guidance document)
• The IVD MDSW regulatory pathway includes steps for prototyping and test licensing, permissions for clinical performance evaluation and importing or manufacturing of new IVDs, manufacturing licenses and import licenses. (See Fig. 2 in CDSCO guidance document)

Registration requirements specific to AI-enabled MDSW

Indian market registrants whose MDSW products feature AI-enabled components should also be aware of requirements to provide dataset composition used for training, validation and testing (such as demographic distribution, geographic origin and clinical diversity). These applicants must also disclose data related to model bias, generalizability and robustness across sub-populations relevant to the Indian medical market.

In addition, manufacturers of AI-enabled MDSW must disclose in their market applications whether datasets used to train their AI models stem from real-world data from public databases or from synthetic data.

Conclusion: MDSW regulatory requirements align India with other medical markets

These and related requirements covering software design and cybersecurity, labeling, clinical evidence and post-market surveillance in the final CDSCO guidance do not deviate significantly from regulatory frameworks for MDSW in other medical markets. This alignment helps establish a clear and potentially more efficient registration pathway in India for medical software manufacturers.