India’s medical device industry is growing rapidly, but with growth comes a greater responsibility to protect patients and ensure ongoing device safety.
Under the Medical Device Rules (MDR) 2017, all manufacturers must maintain a robust Post-Market Surveillance (PMS) system and comply with materiovigilance requirements.
The Materiovigilance Programme of India (MvPI)—run by the Indian Pharmacopoeia Commission (IPC) in collaboration with CDSCO—monitors safety signals, device malfunctions, adverse events, and field safety corrective actions (FSCA).
For manufacturers, proper materiovigilance is not optional:
✔ It is a legal requirement
✔ It protects patients and users
✔ It supports CE, USFDA, and global regulatory submissions
✔ It builds brand trust and prevents market recalls
What Is Materiovigilance?
Materiovigilance is the systematic process of:
- monitoring
- collecting
- evaluating
- reporting
adverse events, component failures, malfunctions, and safety issues of medical devices used in real-world settings.
Unlike pharmacovigilance (for drugs), materiovigilance specifically focuses on medical device safety post-marketing.
Who Manages Materiovigilance in India?
India does not have an online adverse event portal like EUDAMED (EU) or MedWatch (US).
Instead, the system operates through:
1. MvPI (Materiovigilance Programme of India)
Managed by:
- Indian Pharmacopoeia Commission (IPC) – National Coordination Centre
- CDSCO – Central Licensing Authority
- Technical partners & vigilance centres
2. Reporting Mechanisms (Current 2025 System)
Manufacturers report adverse events via:
✔ Official MvPI AER (Adverse Event Reporting) Form
✔ Reporting to CDSCO and State Licensing Authority
✔ FSCA/Recall reports to Zonal offices
✔ Hospital/Institution reporting via MvPI centres
What Must Manufacturers Report Under MvPI?
1. Serious Adverse Events (SAE)
Events resulting in:
- death
- life-threatening situation
- permanent impairment
- disability
- hospitalization or extended hospitalization
- surgical or medical intervention
- significant device malfunction causing harm
2. Device Malfunctions
Failures that could lead to serious harm if repeated.
3. Quality Issues
- leakage
- breakage
- sterility breach
- dimensional variation
- incorrect labeling
- IFU errors
4. Field Safety Corrective Actions (FSCA)
- recall
- withdrawal
- device correction
- software patch
- IFU revision
Materiovigilance Reporting Timelines (CDSCO + MvPI)
| Event Type | Reporting Timeline | Reporting Location |
|---|---|---|
| Death / Life-Threatening SAE | 10 days | IPC (MvPI) + CDSCO + SLA |
| Serious Injury / Serious Deterioration | 30 days | IPC + CDSCO |
| Significant Device Malfunction | 30 days | IPC + CDSCO |
| FSCA / Recall | Within 48 hours | CDSCO Zonal Office + SLA |
| Trend / Signal Detection | Ongoing | Internal PMS |
| Annual PMS/PMCF Reports | Yearly | CDSCO (if required) |
How to Report Adverse Events Under MvPI (Correct Indian Workflow)
Step 1: Collect Complaint Information
From:
- hospitals
- distributors
- users
- sales representatives
- internal QC
Step 2: Classify the Event
- Use MvPI criteria:
- SAE
- Device malfunction
- Quality defect
- FSCA requirement
Step 3: Fill the MvPI AER Form
Includes:
- patient outcome
- device details
- lot/batch
- event description
- root cause
- corrective action
- investigation summary
Step 4: Submit to IPC (National Coordination Centre)
Email: mvpi@ipc.gov.in
Step 5: Inform Licensing Authorities
- CDSCO Zonal Office
- State Licensing Authority
Step 6: Conduct Root Cause Analysis (RCA)
Using methods like:
- 5 Why’s
- Fishbone
- FMEA
- CAPA
Step 7: Submit Final Report
Step 8: Update Technical File & RMF
As per ISO 14971 risk management.
Common Compliance Challenges Faced by Manufacturers
❌ No standardized complaint-handling SOP
❌ Delayed reporting due to incomplete investigation
❌ Not tracking devices by lot/batch
❌ Inadequate PMS trend analysis
❌ Limited training for distributors and field teams
❌ Manual documentation leading to errors
❌ Difficulty preparing FSCA & recall reports
How Bioexcel’s VigiX Software Transforms Materiovigilance in India
VigiX, developed by Bioexcel Lifesciences & Research, is India’s first integrated Materiovigilance Automation Platform designed specifically for MDR 2017 & MvPI compliance.
It solves every problem manufacturers face.
🔥 Key Features of VigiX for Medical Device Manufacturers
1. Automated Complaint & AE Capture
- QR-based complaint forms
- Distributor login
- Hospital portal
- WhatsApp & mobile-friendly intake
2. Automatic Event Classification
VigiX auto-categorizes:
- SAE
- Malfunction
- Quality issue
- FSCA-triggering events
Based on MDR 2017 and MvPI definitions.
3. Built-In Investigation & RCA Tools
- 5 Why’s
- Fishbone
- CAPA management
- Batch/lot tracking
- Device mapping
4. FSCA & Recall Automation
- Generate:
- FSCA report
- Recall plan
- CAPA summary
- Affected batch list
- Communication templates
5. PMS + Materiovigilance Dashboards
- Trend analysis
- Signal detection
- Heatmaps
- Time-to-closure monitoring
- Complaint aging charts
6. Auto-Generate All MvPI & CDSCO Templates
With one click, VigiX creates:
- AER Form
- Investigation Report
- FSCA Format
- Risk Assessment
- Trend Analysis
- Annual PMS Report
7. Fully Audit-Ready System
For:
- CDSCO inspections
- Notified Body audits
- CE & FDA submissions
8. Secure, Cloud-Based, GMP-Compliant
- 21 CFR Part 11
- ISO 13485 integration
- User access control
- Electronic signatures
Why Manufacturers Prefer VigiX Over Manual PMS Systems
| Manual PMS | VigiX (Bioexcel) |
|---|---|
| Slow | Automated |
| Human errors | Rule-based classification |
| Missing documentation | Auto-generated reports |
| No traceability | Full audit trail |
| Hard to detect trends | Real-time analytics |
| Reactively managed | Proactive surveillance |
VigiX reduces the manufacturer’s materiovigilance workload by 60–70%, while improving compliance accuracy by 95%.
Conclusion: Materiovigilance Is Mandatory—Automation Makes It Easier
Materiovigilance compliance in India is now a core regulatory requirement under MDR 2017. Manufacturers must maintain strong PMS, reporting, investigation, and FSCA procedures.
But doing all of this manually is time-consuming and error-prone.
Bioexcel’s VigiX platform empowers manufacturers to manage:
✔ PMS
✔ Materiovigilance
✔ FSCA/Recall
✔ Risk monitoring
✔ Complaint handling
✔ Annual PMS reporting
— all in one powerful, automated system.
For any manufacturer planning for CDSCO compliance, CE marking, global submissions, or scaling to new markets, VigiX is the most efficient and reliable solution.
Frequently Asked Questions (FAQs)
1. Is there any online portal for materiovigilance in India?
No. As of 2025, India uses email-based reporting through MvPI and manual AER forms.
2. Is materiovigilance reporting mandatory?
Yes, under MDR 2017.
3. Who must report adverse events?
Manufacturers, importers, hospitals, distributors, and users.
4. What is the timeline for reporting a device-related death?
Within 10 days to IPC + CDSCO.
5. Can software help with materiovigilance?
Yes—VigiX by Bioexcel is currently the most advanced Indian platform for automated PMS + materiovigilance.
