<h1>Legal risks for connected infusion system in India: compliance with Medical Device Rules, liability, cybersecurity, data privacy, and contracts</h1> A medical-device subsidiary has launched a connected infusion system in India comprising syringe and volumetric pumps plus pump-monitoring software, marketed to improve dosing accuracy, workflow and patient safety. Legally relevant issues include product-regulatory compliance with Indian medical device rules and applicable approvals, device liability and warranty exposure for dosing errors or software failures, cybersecurity and patient-data-privacy obligations arising from remote monitoring and integrated drug libraries, and contractual terms with hospitals (installation, training, maintenance, and indemnities). Procurement and clinical-adoption risks may affect hospital liability and reimbursement; careful documentation, post-market surveillance, and robust risk-management controls are advisable.