The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission (IPC), has released the draft in-vitro diagnostic medical device (IVD-MD) adverse event reporting form and has invited comments from the stakeholders. The manufacturers, regulatory authorities, healthcare professionals, and other stakeholders are invited to provide their feedback and comments on this draft proposal published on February 17, till March 5, 2025.
The Materiovigilance Programme of India (MvPI), under the Indian Pharmacopoeia Commission (IPC), has released the draft in-vitro diagnostic medical device (IVD-MD) adverse event reporting form and has invited comments from the stakeholders. The draft was prepared by MvPI in collaboration with the Central Drugs Standard Control Organisation (CDSCO) and the IVD manufacturers associations, based on the suggestions provided by the stakeholders. "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," said the draft. The manufacturers, regulatory authorities, healthcare professionals, and other stakeholders are invited to provide their feedback and comments on this draft proposal published on February 17, till March 5, 2025. The form is designed to be used by Domestic Manufacturer/Importer/Distributor of In-Vitro Diagnostic Medical Devices, Pathology Laboratory, Blood Donation Centre, Government Programme In-charge and Healthcare Professionals with direct/indirect knowledge of In Vitro Diagnostic Medical Devices Adverse Event.