Materiovigilance Services in India
Materiovigilance is the system for monitoring the safety of medical devices after they reach the market. India’s Medical Device Rules, 2017, mandate post-market surveillance and adverse event reporting for all registered medical devices. The Materiovigilance Programme of India (MvPI), coordinated through the Indian Pharmacopoeia Commission (IPC), serves as the national framework for device safety.
With India’s medical device market projected to reach $50 billion by 2030, and regulatory oversight increasing through CDSCO’s risk-based reclassification of 553+ devices in 2025, materiovigilance compliance is essential for every device manufacturer and importer operating in India.
Our Materiovigilance Services
- Adverse event and incident reporting to CDSCO
- Field Safety Corrective Actions (FSCA) management
- Post-market surveillance planning and execution
- Trend analysis and signal detection for devices
- Post-Market Clinical Follow-up (PMCF) studies
- Coordination with the Indian Pharmacopoeia Commission (IPC)
- MvPI compliance — registration and reporting through the national programme
- Periodic safety reports for medical devices
- Regulatory inspection readiness
Recent Medical Device Regulatory Updates (2025–2026)
- Risk-based reclassification — CDSCO reclassified 553 devices across cardiovascular (351) and neurological (202) segments, with 221 under Class D
- Medical Device Software guidance — CDSCO issued Draft Guidance on Software as Medical Device (SaMD) in October 2025
- UCMPMD launched — India’s first Uniform Code for Marketing Practices in Medical Devices
- Digital certificates — Market Standing Certificates and Non-Conviction Certificates now fully digitalized
- GST reduction — Medical device GST cut to 5% effective September 2025
Who Needs Materiovigilance
All manufacturers, importers, and authorized agents of medical devices registered with CDSCO must maintain a materiovigilance system. This includes Class A through Class D devices — from simple bandages and tongue depressors to implantable cardiac devices and diagnostic imaging equipment.
Related Services
- CDSCO Registration — Medical device registration and import licensing
- Pharmacovigilance — Drug safety monitoring (parallel discipline for pharmaceuticals)
- Clinical Trials — Clinical investigation for medical devices
- India Entry Strategy — Market entry for international device manufacturers