Abstract

REGULATORY OVERVIEW ON MATERIOVIGILANCE SYSTEM IN INDIA

Neha D. Meshram* and Nikita R. Nandanwar

ABSTRACT

Materiovigilance is the monitoring of unfavorable occurrences that arise from patients using medical devices with the goal of improving India's healthcare infrastructure. The word "vigilare" means "to keep awake or alert," while the Greek words "materio" signify materials. The Materiovigilance Programme has been approved by the Ministry of Health and Family Welfare (MoHFW) in order to address possible adverse events associated with medical devices. Capturing and documenting suspected adverse occurrences, such as fatalities, significant declines in health, injuries, and disabilities, is the aim. Adverse occurrences connected to devices, in-vitro diagnostics (IVDs), and medical equipment are documented using the MDAE reporting form. The reporting of major, non-serious, frequent, or atypical adverse events is open to healthcare professionals as well as manufacturers, importers, distributors, and hospital administration.

Keywords: Medical device, Medical device adverse event reporting form (MDAE).