Medical Device Vigilance Programme (MDVP)
What is the MDVP?
The Medical Device Vigilance Programme (MDVP) is CDSCO's post-market safety monitoring system for medical devices, established under Schedule 7 of the Medical Devices Rules 2017. It requires manufacturers, IAR, importers, and healthcare facilities to report adverse events and device-related incidents to CDSCO.
Who must report?
- Manufacturers and IARs of notified medical devices;
- Hospitals and healthcare facilities that use medical devices (user facility reporting).
What must be reported?
A reportable adverse event is any incident where:
- A device has malfunctioned or deteriorated in performance; and
- Reoccurrence of such malfunction could lead to serious injury or death to the patient, user, or other person.
Reporting timelines
| Event severity | Timeline |
|---|---|
| Events that could cause or contribute to death | 30 calendar days |
| Events that could cause or contribute to serious injury | 30 calendar days |
| Urgent (imminent hazard to public health) | Within 10 calendar days |
How to report
Reports are submitted via the SUGAM vigilance module using Forms MD-38 (initial report) and MD-39 (follow-up / final report).
Official source: Medical Devices Rules 2017, Schedule 7; CDSCO — MDVP
Clarify the reportable adverse event definition to: "A reportable adverse event is any incident where a device has malfunctioned or deteriorated in performance, and reoccurrence of such malfunction could lead to serious injury or death to the patient, user, or other person." However, also note that events causing or contributing to serious injury or death must be reported regardless of likelihood of reoccurrence.