The Central Drugs Standard Control Organization (CDSCO) has issued a reminder to manufacturers and importers of their obligations regarding medical device safety. This circular was issued on May 15, 2024.
All medical devices, including in-vitro diagnostics, are regulated under the Drugs and Cosmetics Act and the Medical Devices Rules (MDR). The CDSCO issues licenses to ensure the quality, safety, and performance of these devices.
Importance of Post-Market Surveillance
- License holders must have robust systems for identifying, documenting, and reporting adverse events associated with their devices.
- Post-market surveillance (PMS) is crucial for ongoing monitoring and risk mitigation.
- Timely reporting of adverse events helps identify new risks and allows for corrective actions to protect public health.
The Materiovigilance Programme of India (MvPI)
- This government initiative aims to improve patient safety by monitoring, analyzing, and addressing adverse events related to medical devices.
- The Indian Pharmacopeia Commission (IPC) manages the MvPI program.
- Medical device manufacturers and importers are encouraged to actively participate in MvPI.
In addition to fulfilling existing reporting requirements, license holders are urged to utilize the MvPI platform for reporting adverse events associated with their devices.
Benefits of Reporting
- Enhanced identification and mitigation of medical device risks.
- Improved patient safety through proactive measures.
All medical device license holders are urged to:
- Strengthen their post-market surveillance systems.
- Report adverse events promptly through appropriate channels, including the MvPI platform.
