Materiovigilance programme of India: a step towards patient safety

Abstract

Medical devices which are indispensable part of healthcare delivery system may cause serious events for patients and contribute to healthcare costs. The robust materiovigilance programme will lead to improve the safety of patients and users by reducing the reoccurrence of the incidents. Furthermore, the existing incidents advocate continuous monitoring of medical devices in use, in order to protect the patients’ health. Post marketing surveillance of medical devices is done in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched, at Indian pharmacopeia commission to monitor the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient’s safety. This article reviews regulations and guidance documents regarding medical devices focused on post market vigilance framework in India along with measures for robust implementation of the existing programme.