The Indian government, through the Materiovigilance Programme of India (MvPI) in collaboration with the Central Drugs Standard Control Organization (CDSCO) and IVD manufacturers associations, has released a draft adverse event reporting form for In-vitro Diagnostic Medical Devices (IVD-MDs).
This draft form was published on February 17, 2025. Stakeholders are invited to provide their feedback and comments on it by March 5, 2025.
This initiative aims to establish a standardized system for capturing and analyzing adverse events related to IVD-MDs, ensuring patient safety and product quality. The draft form, developed based on stakeholder suggestions, is intended to facilitate the reporting process for manufacturers, regulatory authorities, healthcare professionals, and other relevant parties.
Key Points
The purpose of the draft IVD-MD adverse event reporting form is to establish a standardized system for reporting adverse events related to IVD-MDs. It also aims to enhance patient safety and product quality.
Call for Stakeholder Feedback
Manufacturers, regulatory authorities, healthcare professionals, and other stakeholders are encouraged to provide feedback. Comments received after March 5, 2025, will not be considered.
Comments can be submitted via email to naveen.v96@gov.in.
The MvPI encourages all interested parties to review the draft form and submit their comments before the deadline to contribute to the development of a robust adverse event reporting system for IVD-MDs.
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