Lessons from global materiovigilance systems: What India can learn?
Aditya Vikram Singh1, Farida Ahmad1, Syed Shariq Naeem1
1Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
Perspectives in Clinical Research
|February 16, 2026
Summary
Materiovigilance, the monitoring of medical device adverse events, is crucial for patient safety. Developed nations have robust systems, while India
Area of Science:
- Medical device safety and regulatory science.
- Public health and healthcare system strengthening.
Background:
- Medical devices are vital in healthcare but carry risks from defects and adverse events.
- Materiovigilance is essential for monitoring, assessing, and preventing medical device-related harm.
- Developed countries have mature materiovigilance systems with strong regulatory oversight and reporting.
Purpose of the Study:
- To analyze the current state of materiovigilance globally and in India.
- To identify challenges in India's evolving materiovigilance program.
- To propose strategies for strengthening India's medical device safety framework.
Main Methods:
- Comparative analysis of international materiovigilance best practices.
- Review of India's Materiovigilance Programme (2015).
- Identification of challenges including reporting, awareness, and enforcement.
Main Results:
- Established nations utilize comprehensive postmarket surveillance, emphasizing real-time reporting and accountability.
- India's program faces challenges: limited mandatory reporting, low awareness, underreporting, and inconsistent enforcement.
- Global best practices offer a roadmap for India's materiovigilance enhancement.
Conclusions:
- Strengthening India's materiovigilance requires improved reporting infrastructure and stakeholder engagement.
- Enhanced regulatory policies and enforcement are critical for ensuring medical device safety in India.
- Adopting global best practices can significantly bolster India's medical device safety and reliability.
Keywords:
Adverse eventsMateriovigilance Programme of Indiamateriovigilancemedical deviceregulatorysurveillanceMore Related Videos
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