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CDSCO

Draft guidance document on conduct of Medical Device Software under MDR 2017


regulatory illustration
Regulatory update
Importer & Manufacturer   |   Source: CDSCO
Published On: 21-10-2025
Enforcement Date: 21 October, 2025
Draft guidance document on conduct of Medical Device Software under MDR 2017

The CDSCO has released a draft guidance document for stakeholder comments on the regulation of Medical Device Software under MDR-2017. It covers definitions, classification, applicable standards, QMS requirements, licensing pathways, and post-marketing obligations for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), including IVD software.


The draft guidance by CDSCO aims to clarify regulatory requirements for Medical Device Software under the Medical Devices Rules, 2017. It applies to software classified as SiMD (embedded in hardware) and SaMD (standalone software), including in-vitro diagnostic (IVD) software. The document outlines risk-based classification (Classes A–D), applicable standards (ISO 13485, IEC 62304, etc.), and mandates Quality Management Systems for manufacturers and importers. It details licensing authorities, submission modes via NSWS and MD Online portals, and documentation for test licenses, clinical investigations, and marketing approvals. Post-marketing surveillance, software change management, and cybersecurity considerations are emphasized. Stakeholders are invited to provide comments through the official Google Form link.

Applicable For: Importer & Manufacturer
Reference Number: F. No. MED-16028/212024-eoffice Notification Link

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