New Delhi, 15 May 2024 – The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, has issued a new circular (File No. MED-12/30/2024-eoffice) mandating strict compliance with post-market surveillance (PMS) requirements for all medical device license holders. This directive aims to enhance patient safety and ensure the quality and performance of medical devices available in the Indian market.

According to the circular, all medical devices, including in-vitro diagnostic devices, are now regulated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. The CDSCO emphasizes the necessity for license holders to establish systems for the timely identification, documentation, and reporting of adverse events associated with their devices.

Key Highlights of the Circular

1. Mandatory Licensing and Compliance:
   • All medical devices and in-vitro diagnostic devices require a license for import or manufacture. This process involves thorough registration and adherence to regulatory standards.
   • Licenses are issued with specific conditions to ensure quality, safety, and performance.
2. Post-Market Surveillance (PMS):
   • License holders must implement PMS to monitor and address potential risks.
   • PMS helps identify unrecognized risks and analyze the frequency of known risks.
   • Timely reporting of adverse events is crucial for mitigating risks and protecting public health.
3. Materiovigilance Programme of India (MvPI):
   • Launched to enhance patient safety by monitoring adverse events related to medical devices.
   • Indian Pharmacopoeia Commission (IPC) serves as the National Coordination Centre for MvPI.
   • Active participation of medical device industries in MvPI is encouraged.

Action Required

All medical device license holders are required to use the Materiovigilance Programme of India (MvPI) platform for reporting adverse events and serious adverse events. For training and support in adverse event reporting, stakeholders can contact [email protected]. The MvPI guidance documents provide comprehensive instructions on reporting adverse events related to medical devices, aiming to improve the safety and efficacy of medical devices. For further understanding, read the guidance document available on the IPC website.

Conclusion
This initiative underscores the commitment of the Ministry of Health & Family Welfare to safeguard public health by ensuring the highest standards in medical device regulation and monitoring.  Morulaa specializes in helping medical device manufacturers and importers navigate the complex regulatory landscape in India. With expertise in CDSCO regulatory approvals and a focus on compliance, Morulaa offers comprehensive support to ensure timely and accurate adherence to regulatory requirements, including post-market surveillance and adverse event reporting. For further information on how Morulaa can assist with CDSCO compliance, visit www.morulaa.com.