ADRMS User Manual for Stakeholders on Medical Device Adverse Event Reporting

The Indian Pharmacopoeia Commission (IPC), through the National Coordination Centre–Materiovigilance Programme of India (NCC-MvPI), has issued the ADRMS User Manual for Stakeholders to guide stakeholders in reporting Medical Device Adverse Events (MDAEs) through the ADRMS portal.

Key points include:

1. Provides step-by-step guidance for logging into ADRMS and submitting an MDAE report.
2. The reporting form covers report information, medical device details, event details, patient information, medical and past drug history, hospitalisation/death information, tests and procedures, and assessment.
3. Reports may be submitted as initial, follow-up, final or trend reports.
4. Medical devices and In Vitro Diagnostics (IVDs) must be classified according to the Medical Devices Rules, 2017.
5. Manufacturer, importer and distributor details, device identification and usage information must be provided where applicable.
6. The assessment section includes root cause analysis, investigation actions and corrective/preventive actions.
7. The completed report must be reviewed and saved through ADRMS for submission to NCC-MvPI, IPC.