What is Materiovigilance?
In the medical world, it's not just drugs that need monitoring — medical devices also come with safety concerns. Materiovigilance refers to the systematic monitoring, recording, and assessment of adverse events or risks related to medical devices after they’ve been placed on the market.
In India, this crucial responsibility is handled under the Materiovigilance Programme of India (MvPI), a national initiative aimed at ensuring medical device safety for healthcare professionals and patients alike.
When Was MvPI Launched?
- Date of Launch: 6th July 2015
- Launched by: Indian Pharmacopoeia Commission (IPC)
- Approved by: Ministry of Health and Family Welfare, Government of India
- Objective: To collect, analyze, and respond to medical device-related adverse events in India
This initiative was a major step toward aligning India’s post-market surveillance system with global regulatory practices, such as those seen under the European MDR or the US FDA's MedWatch system.
What Tools Does MvPI Offer?
To streamline reporting and communication, MvPI developed a suite of tools launched on 8th February 2019:
MvPI Reporting Tools:
- Medical Device Adverse Event (MDAE) Forms
- Available in English & Hindi
- For license holders, healthcare professionals, hospitals, etc.
- MDAE Forms for Consumers/Users
- Designed for patients or laypersons to report issues
- Field Safety Corrective Action (FSCA) Form
- Used when a manufacturer or distributor initiates a recall, warning, or product correction
- Registered Medical Devices Information Portal
- Repository of officially registered medical devices
- PPE Form
- Specific to adverse events involving Personal Protective Equipment
How to Report a Medical Device Adverse Event (MDAE)?
Whether you're a healthcare provider, manufacturer, or user, reporting an issue is straightforward:
For MDMC Reporters (Medical Device Monitoring Centres):
- Fill the MDAE form from www.ipc.gov.in
- Submit to the Coordinator or Research Associate of your respective MDMC
For Non-MDMC Reporters:
- Send the completed form to:
- Your nearest MDMC
- Or to the National Collaborating Centre
- Alternatively, you can email the form to:
This system ensures inclusivity — even patients and device users can report incidents.
What Are the Reporting Timeframes?
Understanding when to report is just as important as how. The timeframes are defined by the severity of the event and the type of reporter.
| Reporter | What to Report | Report To | When to Report |
|---|---|---|---|
| MAH / Manufacturer / Importer / Distributor | Deaths, serious injuries, device malfunctions, recalls | CDSCO / IPC | Within 15 calendar days |
| Hospitals / User Facilities | Deaths & serious injuries | MAH / IPC / CDSCO | 15 days for serious, 30 days for non-serious |
Failure to comply may result in regulatory scrutiny or penalties.
Why is Materiovigilance Important?
India is emerging as a global hub for medical devices — both as a user and manufacturer. With that growth comes the responsibility to:
- Protect patients from faulty or harmful devices
- Improve product quality over time
- Build public trust in India's medtech ecosystem
- Help regulators take action faster, such as recalls or design changes
Final Thoughts
The Materiovigilance Programme of India (MvPI) is a vital system that empowers both professionals and the public to report safety issues related to medical devices. If you're part of the healthcare or medical device industry, knowing how to report and when to report is not just a responsibility — it’s part of ethical medical practice.
Let’s build a safer, smarter healthcare system together. 🛡️
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