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CDSCO Digital Health Regulatory Framework

Overview​

India is developing a digital health regulatory framework that addresses:

  • Software as a Medical Device (SaMD) — standalone software with medical intended use;
  • AI/ML-based medical devices — software using artificial intelligence or machine learning for diagnosis, prognosis, or treatment;
  • Mobile medical applications — apps functioning as medical devices;
  • Connected and IoT devices — devices that communicate with other systems or cloud services;
  • Telemedicine platforms — intersection of telemedicine regulations and device regulations.

Current status​

As of 2026, CDSCO has not yet published a dedicated comprehensive SaMD guidance document. SaMD is classified under the existing MDR 2017 classification framework using IMDRF SaMD principles. CDSCO has signalled intent to publish specific SaMD guidance aligned with IMDRF N12 and N23 documents.

National Digital Health Mission (NDHM)​

The National Digital Health Mission (NDHM) / Ayushman Bharat Digital Mission (ABDM) is the government's overarching digital health ecosystem initiative, establishing a digital health ID, health records framework, and interoperability standards. Medical device manufacturers with connected devices should consider ABDM integration requirements.

Official sources: CDSCO; ABDM — NHA; IMDRF SaMD guidance