Materiovigilance programme of India-An overview
Dhamini M.2**, Jawahar N.1*, Vignesh M.2***
1Assistant Professor, Department of Pharmaceutics, JSS College of Pharmacy, Ooty-643001.
2Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, Ooty-643001.
*Corresponding Author E-mail: email@example.com
Online published on 30 April, 2021.
Medical devices are defined as any instrument, apparatus or materials used for diagnosis, treatment or cure of any undesirable ailments which cause health issues to the people. These medical devices during their use can cause certain undesirable adverse events that need to be monitored and solved. In India, a programme has been initiated which is known as the “Materiovigilance Praogramme of India" to monitor the adverse events that occur from the use of the medical device and to take necessary actions to solve the adverse actions occurred from the use of medical devices. Once the institution is recognized as a medical device monitoring centre the adverse events are reported online in a form that is available on the Indian Pharmacopoeia Commission website. The centre forwards the medical device adverse event reports to the national collaborating centre (The Sree Chitra Tirunal Institute for Medical Sciences and Technology or to the national coordination centre (Indian Pharmacopoeia Commission). If the reports are valid the adverse events are solved and prevented. If the reports are invalid, it is sent back to the respective centre for recorrection. Based on the reports a solution is decided and the adverse events are solved and prevented.
Medical devices, Materiovigilance, Undesirable ailments, Undesirable adverse events, Materiovigilance, Monitoring.