Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event reporting form
Draft In-vitro Diagnostic medical device (IVD-MD) adverse event reporting form for Comments
Published on: 17/02/2025 Last Date for Submission of Comments: 05/03/2025
Subject: Inviting comments from the stakeholders for the draft IVD-MD adverse event reporting form.
Based on the suggestions provided by the stakeholders, MvPI in collaboration with the CDSCO and the IVD manufacturers associations, has created this draft IVD reporting form. This form will help the stakeholders to capture the adverse events related to In-vitro Diagnostic medical device (IVD-MD). The content of this draft reporting form is not final and the text may be subjected to revision before being finalized by the MvPI.
Manufacturers, regulatory authorities, healthcare professionals, and other stakeholders are invited to provide their feedback and comments on this draft proposal. Comments received after the last date will not be considered by the MvPI.
This form is intended to collect information on In-Vitro Diagnostic Medical Devices Adverse Event in India. The form is designed to be used by Domestic Manufacturer / Importer / Distributor of In-Vitro Diagnostic Medical Devices, Pathology Laboratory, Blood Donation Centre, Government Program In-charge and Healthcare Professionals with direct/indirect knowledge of In Vitro Diagnostic Medical Devices Adverse Event.
Please send any comments you may have on this draft document to naveen.v96@gov.in before the last date for comments.
Draft form can be downloaded from CDSCO website and the same is shared here for reference :
Last Date for Submission of Comments: 05/03/2025
Inviting all manufacturers of IVDs, Importers, Distributors of IVDs, Pathology Labs, Blood Banks and other key stakeholders to submit their feedback before the cut off date.
Share the Post Via :
Healthcare Events 
Leave a comment