NCC-MvPI Issues ADRMS User Manual for Medical Device Adverse Event Reporting

The National Coordination Centre–Materiovigilance Programme of India (NCC-MvPI), Indian Pharmacopoeia Commission (IPC), has issued the ADRMS User Manual for Stakeholders, Version 00, released on 18 August 2025. The manual provides a structured process for reporting Medical Device Adverse Events (MDAEs) through the Adverse Drug Reactions Monitoring System (ADRMS) portal. It explains nine reporting sections, including report information, medical device information, event details, patient details, medical and past drug history, hospitalization/death information, tests and procedures, assessment, and preview/save. The manual also provides instructions for device risk classification under the Medical Devices Rules, 2017, manufacturer/importer details, device identification information, adverse event reporting, trend reporting, investigation, root-cause analysis, corrective/preventive actions and device history review. The manual is intended to facilitate systematic reporting and monitoring of medical device safety under the Materiovigilance Programme of India.