MvPI Hospital Guidance Document (Version 1.3) – Guidance Document for Hospitals in India
The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Devices related incidents / Adverse Events (MDAE) Version 1.3 was published by The Indian Pharmacopoeia Commission (IPC), National Coordination Centre for Materiovigilance Programme of India (MvPI)
The document is intended to help hospitals establish practical systems for medical-device adverse-event (MDAE) safety monitoring and reporting under MvPI.
Key objectives — MvPI Hospital Guidance Document (Version 1.3)
1. Provides a standardized framework to monitor, identify, document, report, assess, and manage medical-device-related incidents and suspected adverse events.
2. Covers device malfunctions, user errors, and other safety concerns, not only adverse events.
3. Offers practical guidance for hospitals and healthcare facilities to implement the Materiovigilance Programme of India (MvPI) effectively.
4. Clarifies the roles and responsibilities of hospital staff in detecting, reporting, investigating, and managing device-related safety issues.
5. Strengthens hospital systems through better incident detection, internal communication, documentation, investigation, corrective and preventive actions, and follow-up.
6. Encourages participation from healthcare professionals, MDMCs, patients, consumers, caregivers, and other device-safety stakeholders.
7. Aims to build a proactive medical-device safety culture, improving patient safety and the overall quality of healthcare delivery.
