CDSCO Releases Updated Draft Guidelines for AI-Enabled Medical Device Software

As a physician who increasingly relies on digital health tools, I find India’s latest move hugely significant: the CDSCO has published a draft guidance document for medical-device software (SaMD and SiMD), including AI/ML-based applications.

What this means for us at the bedside:

• This regulation clarifies how software used in diagnostics, monitoring, and therapy is classified and governed — helping ensure safety, effectiveness, and patient protection.

• For AI-driven tools especially, the draft includes provisions on clinical evaluation, algorithm changes, and quality-management systems.

• As doctors, we must start asking: Has the software been validated? What risk class does it fall under? Are updates managed transparently?

• On the positive side, this could accelerate adoption of trusted digital health tools in Indian clinics — making health-tech more credible, and better aligned to clinical needs.

• But transition may require effort: staff training, data-privacy setup, and post-market vigilance will be critical for safe integration.