1. Medical Device Safety: India’s Perspective
Ritu Jain, V. Kalaiselvan, A. Pramod Kumar
Materiovigilance Programme of India
Indian Pharmacopoeia Commission, Ghaziabad , U.P, India 2
 Poster
Number: 31
What is the scope of Materiovigilance Programme of India?
MvPI came into existence to create a nation-wide system for patient safety monitoring.
Analyse the benefit-risk ratio of medical devices, generate evidence-based information on safety of medical devices, support Central Drugs Standards Control Organization (CDSCO) in the decision-making process on use of medical devices.
Communicate the safety information on use of medical devices to various stakeholders to minimise the risk, emerge as a national centre of excellence for Materiovigilance activities.
Collaborate with other healthcare organisations for exchange of information and data management.
Materiovigilance means close monitoring of any undesirable performance or characteristic fluctuations of a medical device by means of a system which is capable of identifying, collecting, reporting with estimate of undesirable occurrences and reacting to them with field safety corrective actions or device recall during post -marketing phase of a Medical Device.
Ministry of Health and Family Welfare, Government of India has approved the commencement of “Materiovigilance Programme of India (MvPI)" with Indian Pharmacopoeia Commission, Ghaziabad.
The National Coordinating Centre-MvPI to monitor the safety of medical devices in the country was formally launched on July 6, 2015 at Indian Pharmacopoeia Commission (IPC), Ghaziabad by The Drugs Controller General (India).
The programme also aims to create awareness among healthcare professionals and others about the importance of Medical Device Adverse Event (MDAE) reporting and to monitor the benefit-risk profile of medical devices.
MvPI authoritatively generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.
Mission of Materiovigilance Programme of India:
Safeguard the health of Indian population by ensuring that the benefits of use of Medical Devices outweigh the risks associated with its use.
 Objective of Materiovigilance Programme of India:
To improve the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood reoccurrence of an adverse event associated with the use of Medical Devices.
No medical device is completely devoid of risk. Therefore, it is essential to have a monitoring system to ensure patients and users safety.
Disclosure : Authors declare no conflicts of interest.