The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), 2017 with an aim to clarity on regulatory requirements for medical device software and align India’s framework with globally harmonized practices.
The guidance outlines comprehensive provisions related to the scope, definitions, classification, applicable standards, technical documentation, and quality management system (QMS) requirements specific to medical device software.
According to CDSCO, the draft document will serve as a reference for applicants seeking licences to manufacture or import medical device software for sale and distribution in India. It is intended to streamline the approval process and ensure that such products meet international safety, quality, and performance standards.
The Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies, has welcomed the release of the draft guidance commended CDSCO for its proactive step in framing a comprehensive regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), including artificial intelligence (AI), machine learning (ML), and cloud-based medical applications.
“This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies. By providing clarity on definitions, classification, and quality management requirements, it creates a foundation for safe, innovative, and globally competitive MedTech software solutions from India,” said Pavan Choudary, Chairman, MTaI.
“We look forward to continuing our engagement with the regulator to ensure that the final framework remains innovation-friendly, risk-proportionate, and harmonized with global best practices,” he added.
MTaI also highlighted that while the guidance is a welcome step, the final version should:
* Streamline compliance requirements for low-risk SaMDs to ensure regulatory proportionality and ease of implementation.
* Align technical and quality standards with global best practices, including those developed by IMDRF, US FDA, and the EU MDR framework.
* Provide greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices.
MTaI reaffirmed its commitment to supporting the Government of India in building a progressive, predictable, and globally harmonized regulatory environment for medical technologies and digital health innovations.