File No.: MED-16028/2/2025-eoffice dated July 21, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940; Medical Devices Rules, 2017 (MDR-2017)
Pursuant to Gazette Notification S.O. 648(E) dated 11.02.2020 issued by the Ministry of Health & Family Welfare, all medical devices are regulated under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017. Medical Device Software intended for medical purposes is regulated under the same provisions. A Draft Guidance Document on Medical Device Software was published vide File No. MED-10028/2/2024-eoffice dated 21.10.2025 for public comments. Comments received from stakeholders were reviewed in consultation with experts.
The final Guidance Document on Medical Device Software, Doc No. CDSCO/MD/GD/MDSW/01/2026, has been prepared and is attached to the circular. The document addresses the regulatory framework, classification principles, applicable safety and performance requirements, documentation expectations, quality management considerations, and post-market obligations for Medical Device Software under MDR-2017.
All stakeholders are advised to refer to this document while submitting applications for regulatory approvals under MDR-2017.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.
