India’s CDSCO Issued Final Guidance on Medical Device Software in July 2026

CDSCO, India’s regulator for medical devices and in vitro diagnostics, has issued final guidance on registration and market access requirements for products that qualify as medical device software. Reports describe a 62-page document, numbered CDSCO/MD/GD/MDSW/01/2026 and dated 21 July 2026, that brings CDSCO’s approach to software, including in vitro diagnostic software, into one operational reference under the Medical Devices Rules, 2017. The guidance covers test licensing, clinical investigation, manufacturing licensing and import licensing.

The guidance is interpretive. Legal commentators describe it as an explanation of how the existing Medical Devices Rules apply to software across its lifecycle, not a standalone software law and not a new approval route. It applies only to software that falls within the definition of a medical device under the Rules and is intended for a medical purpose, so intended use determines both whether a product is regulated and which registration pathway and risk class apply.

The full text of the CDSCO document was not accessed directly for this brief. The points below are drawn from law-firm and consultancy summaries, and sponsors should verify details against the document published on the CDSCO website.

CDSCO released the draft guidance on 21 October 2025, describing it as India’s first dedicated effort to align the regulation of medical software with international practice. The draft distinguished software as a medical device, meaning standalone software that performs medical functions, from software in a medical device, meaning software embedded in or integral to hardware. Under the draft, embedded software took the risk class of its host device, while standalone software was classified by intended use. Industry associations welcomed the draft but asked for greater clarity on several areas, including the evaluation of AI and machine learning products.

According to commentators, the final version replaces the two categories with a single term, medical device software (MDSW). Software that drives or influences a hardware device is reported to take that hardware’s risk class. The guidance does not introduce a separate classification system for AI; software is classified under the same Class A to D system that applies to other devices under the Medical Devices Rules, 2017.

Summaries of the final guidance indicate that manufacturers need a quality management system covering the full software lifecycle and a software bill of materials that is kept up to date and linked to vulnerability monitoring. The guidance addresses safety and performance, technical documentation, cybersecurity and post-market obligations, and commentators note that it expects software updates and algorithm drift to be managed after deployment.

For AI-based software, an algorithm change protocol is described as optional, applying wherever applicable, and not as a mandatory requirement for every product. One consultancy summary maps licence applications to the existing forms under the Rules: MD-3 and MD-5 for Class A and B devices, MD-7 and MD-9 for Class C and D devices, and MD-14 and MD-15 for imports. This mapping comes from a secondary source and should be confirmed against the CDSCO document.

Developers of diagnostic algorithms, clinical decision support tools, digital therapeutics and IVD software intended for the Indian market should first assess whether their product meets the medical device definition and then confirm its class, because this determines the registration pathway and the licence forms that apply. Foreign developers supplying India will need to follow the import licensing route described in the guidance.

Sponsors with existing software products should review their technical files for lifecycle documentation, software bill of materials and cybersecurity evidence, and decide whether an algorithm change protocol would help manage planned model updates. Pubrica is not affiliated with CDSCO and does not provide legal advice; the official guidance and the Medical Devices Rules, 2017 remain the authoritative sources.