MTaI Applauds CDSCO’s Draft Guidance On Medical Device Software
The Medical Technology Association of India (MTaI), representing leading research-based medical technology companies, has welcomed the release of the Draft Guidance Document on Medical Device Software by the Central Drugs Standard Control Organization (CDSCO).
The draft guidance aims to establish a structured regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), encompassing emerging technologies such as 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“This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies.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. He added, “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.”
MTaI also emphasised that while the draft guidance is a progressive step, the final version should:
- Streamline compliance requirements for low-risk SaMDs, ensuring proportional regulation and ease of implementation.
- Align technical and quality standards with global benchmarks, including those from IMDRF, US FDA, and EU MDR frameworks.
- Offer greater clarity on clinical evaluation protocols and algorithm change management, especially for AI/ML-based medical devices.
Reiterating its support for regulatory advancement, MTaI affirmed its commitment to partnering with the Government of India in building a predictable, innovation-friendly, and globally harmonised ecosystem for medical technologies and digital health solutions.
