Last Updated on May 24, 2024 by The Health Master
Medical Device
The Central Drugs Standard Control Organisation (CDSCO) has emphasized the importance of timely reporting adverse events associated with medical device to the Materiovigilance Programme of India (MvPI).
This call to action comes as all medical device, including in-vitro diagnostics, are now subject to licensing under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.
Shifting to a Licensing Regime
Previously, medical device were categorized as Class A, B, C, and D. Over the past two years, all classes have been brought under a licensing regime.
This licensing system, with its defined conditions, guarantees the quality, safety, and performance of medical device available in the Indian market.
Additionally, it ensures compliance with robust quality management systems.
The CDSCO, in a recent circular, highlighted the critical role of medical device license holders in establishing robust systems and processes for:
- Timely identification: Recognizing potential issues with medical device.
- Thorough documentation: Recording all relevant details of adverse events.
- Efficient reporting: Submitting timely reports of adverse events to the MvPI.
Post-Market Surveillance (PMS): Crucial for Identifying and Addressing Risks
Post-market surveillance (PMS) plays a vital role in ensuring the ongoing safety and performance of medical device.
This process helps identify and address any potential risks or adverse events associated with a device after it has been marketed.
Timely reporting of adverse events offers several advantages:
- Identification of Unforeseen Risks: It allows for the discovery of previously unknown risks associated with medical device.
- Frequency Analysis of Known Risks: By analyzing the frequency of reported adverse events, authorities can gain insights into the prevalence of existing risks.
- Proactive Risk Mitigation: Timely reporting empowers manufacturers and regulatory bodies to take appropriate measures to mitigate risks and safeguard public health.
Medical Device Risk Management
“The MvPI is a crucial platform for reporting adverse events, conducting coordinated analysis, and improving overall medical device safety,” stated Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India).
He encouraged all license holders to leverage the MvPI platform for reporting any adverse or serious adverse events associated with their devices.
This comprehensive reporting will enhance the process of identifying and mitigating medical device risks.
Dr. Raghuvanshi further emphasized, “We urge all license holders to take necessary steps for timely reporting of adverse events related to medical device to the MvPI.
Guidance documents outlining the effective utilization of MvPI are readily available on the Indian Pharmacopoeia Commission (IPC) website.”
The CDSCO has also opened communication channels for those seeking training to improve their understanding and proficiency in adverse event reporting processes.
Industry representatives and regulators can reach out to the IPC via email for training inquiries.
The MvPI:
The MvPI, launched by the Union Ministry of Health and Family Welfare, plays a critical role in improving patient safety in India. It functions by:
- Monitoring: Closely tracking the use of medical device.
- Recording: Documenting all reported adverse events and associated risks.
- Analyzing: Investigating the root causes of adverse events.
- Suggesting Action: Recommending appropriate actions to regulatory bodies to enhance patient safety.
The IPC serves as the National Coordination Centre for MvPI.
Encouragingly, the program actively seeks participation from a broad spectrum of stakeholders, including:
- Healthcare professionals
- General public users
- Patients
- Medical device industries
By fostering collaboration among these stakeholders, the MvPI strives to create a significant impact on patient safety outcomes in India.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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