For the first time, India’s Central Drugs Standard Control Organization (“CDSCO”) has issued a Draft Guidance on Medical Device Software to regulate software-based medical devices, including AI-based devices. This guidance aims to clarify the classification, licensing, validation, and post-marketing surveillance of Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD).
The draft guidance attempts to update the gap in the Medical Device Rules of 2017, which does not take into account digital and artificial intelligence technologies. The draft guidance establishes a risk-based classification system consistent with international standards – it requires manufacturers to implement quality management systems (QMS) and comply with rigorous licensing and documentation regulations.
It also attempts to impose the requirements of post-market surveillance, regular cybersecurity reporting, and an Algorithm Change Protocol to track updates to software or AI applications. The draft guidance attempts to align the developing regulatory framework for digital health in India with international standards.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.