Table of ContentsIntroductionMateriovigilance Program of India (MvPI)ConclusionIntroductionThe word materiovigilance is a combination of two words – “material” which means “a physical substance from which things can be made” and “ vigilance” which means “more particular attention, in particular in order to detect a possible danger”. Thus, the term materiovigilance is defined as “close monitoring of any adverse event resulting from a medical device by means of the establishment of a system that includes the identification, collection, reporting and estimation of events undesirable data and the response to them, or security corrective actions after their occurrence. phase 1 post-marketing”. Any instrument, device, machine, device, implant, in vitro reagent, software, or other item intended for use by humans for specific medical purposes is termed as a medical device. Examples of medical devices include a wide variety of devices, such as thermometers which are very commonly used and advanced medical ventilators used in intensive care units. Indeed, today's medical care relies heavily on medical devices for the prevention, diagnosis, treatment and investigation of illnesses and injuries. Say no to plagiarism. Get a tailor-made essay on “Why Violent Video Games Should Not Be Banned”? Get an original essay The use of medical devices can also lead to certain adverse events, for example incorrect test results from a glucometer, malfunction of an infusion. a pump resulting in patient injury, a faulty automated external defibrillator (AED) resulting in electrical burns to a patient or healthcare provider, etc. Thus, it becomes necessary to put in place a system so that such events can be reported and noted by an agency in order to help identify the risks associated with medical devices, remove these medical devices from the market and eliminate the dangers that such adverse events occur in the future. And this void was filled by the concept of materiovigilance. Indian Materiovigilance Program (MvPI) The Drugs and Cosmetics Act, 1940 lists the rules governing medical devices in Schedule R1. These rules relate to the manufacturing, distribution, sale, import and export of medical devices in India. The Materiovigilance Program of India was approved by the Ministry of Health and Family Welfare on 02/10/2015 and it was launched on 07/06/2015 by the DCGI at the Indian Pharmacopoeia Commission at Ghaziabad. It was decided that Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, would be the national collaboration centre; The National Health System Resource Center (NHSRC), New Delhi, will be the technical support partner, and the Central Drugs Standard Control Organization (CDSCO), New Delhi, will act as regulator. The objective of this program is to monitor adverse events associated with medical devices (MDAE), to raise awareness among health service providers of the value of reporting these adverse events and also to monitor the benefit-risk ratio of medical devices. The program also aims to provide independent, evidence-based data and guidance on the safety of medical devices and communicate the results to stakeholders. Stakeholders involved are professional staff of IPC, SCTIMST, NHSRC and any similar institutions that would serve as stakeholders.