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