Materiovigilance refers to a comprehensive system that involves evaluating, tracking, recognizing, gathering, documenting, and examining any undesirable incidents resulting from the use of medical devices. While pharmacovigilance focuses on monitoring medications after they have been introduced to the market, materiovigilance deals with postmarket monitoring of medical equipment, including in vitro diagnostics. India’s medical device market is valued at USD 3.1 billion, but until recently, there was a lack of a well-established surveillance system to monitor and address adverse events associated with medical devices.


Materiovigilance Programme of India

The Materiovigilance Programme of India (MvPI) to monitor the safety of medical devices in the country has been approved for commencement by the Ministry of Health & Family Welfare, Govt. of India. The MvPI is formally launched on 6th July 2015 at IPC, Ghaziabad by DCG(I). The Indian Pharmacopoeia Commission functions as National Coordination Centre for MvPI. Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST) will function as National Collaborating Centre. National Health Systems Resource Centre (NHSRC) under MoHFW, Govt. of India working as technical support and resource center.


  • Creating a countrywide plan for monitoring patient safety
  • Examining the benefit–risk ratio related to a medical device
  • Creating evidence-based data for medical equipment associated with adverse events
  • Supporting the Central Drugs Standard Control Organisation (CDSCO) in making decisions about medical device regulation in the country
  • Exchanging safety-based information with various stakeholders in the industry
  • Collaborating with other healthcare organizations and international agencies for information exchange and data management



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