The Central Drugs Standard Control Organization (CDSCO) has released a guidance document on Medical Device Software to improve understanding of the regulatory requirements under the Medical Devices Rules, 2017. The document explains the scope, classification, quality management system requirements, licensing pathways, clinical investigation requirements, and regulatory submission process for medical device software intended for the Indian market.
The Central Drugs Standard Control Organization (CDSCO) has issued a guidance document on Medical Device Software (MDSW) to help stakeholders understand the regulatory framework under the Medical Devices Rules, 2017. The guidance explains how software intended for medical purposes is regulated in India and provides clarity on the applicable licensing, classification, quality, and compliance requirements. It also highlights the responsibilities of stakeholders throughout the product lifecycle.
Key highlights include:
- Explains the scope of Medical Device Software and identifies software covered under the Medical Devices Rules, 2017.
- Provides guidance on risk-based classification principles for software-based medical devices.
- Describes the licensing pathways for manufacturing and importing Medical Device Software in India.
- Outlines quality management system, clinical investigation, and performance evaluation requirements where applicable.
- Includes guidance on regulatory documentation, post-market responsibilities, and applicable regulatory standards.
- Provides examples and supporting information to help stakeholders understand regulatory expectations.
The guidance is intended to support manufacturers, importers, authorised representatives, and other stakeholders in understanding and complying with the regulatory requirements for Medical Device Software in India.