New classification and compliance rules for software used in diagnosis, treatment and clinical decision-making
Hospitals and health-tech vendors must verify whether their software qualifies as a regulated medical device
Software intended for diagnosis, monitoring or treatment must be classified by risk and regulated accordingly.
Manufacturers must obtain the applicable license before distribution of regulated software in India.
Aligned with DPDP requirements, including consent, encryption and breach notification obligations.
Documented evidence of safety and performance, including validation for AI and decision-support tools.
Ongoing monitoring, incident reporting and version control once the software is in clinical use.
Facilities must verify regulatory status of software and devices before clinical deployment.
Determine whether your product is medical device software or general wellness software
Prepare quality management system and technical documentation
Submit clinical and performance evidence for the applicable risk class
Audit clinical software inventory and confirm regulatory approvals
Review vendor contracts for compliance and data protection clauses
Document staff training and safe-use procedures for regulated software
Our regulatory experts help you classify, document and stay compliant with CDSCO requirements