The Ministry of Health and Family Welfare (MoH&FW) on February 17, 2025, issued a notification regarding inviting comments from the stakeholders for the draft IVD-MD adverse event reporting form.
The following has been stated: -
•The Indian Pharmacopoeia Commission (IPC) invites stakeholders to comment on the draft In-vitro Diagnostic Medical Device (IVD-MD) adverse event reporting form by March 05, 2025.
•The form, created with input from various stakeholders, helps capture adverse events related to IVD devices. Manufacturers, healthcare professionals, and others who report issues will use it.
•The form includes sections on device details, event description, patient information, and corrective actions. Feedback can be sent to designated emails before the deadline. The final version will be based on stakeholder input.
The detailed notification is given in the document below.
