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Perspect Clin Res. 2018 Oct-Dec;9(4):175-178. doi: 10.4103/picr.PICR_26_18.

Materiovigilance: An Indian perspective.

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1
Department of Pharmacology, All Indian Institute of Medical Science, Bhubaneswar, Odisha, India.

Abstract

Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track 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.

KEYWORDS:

Adverse event; medical device; postmarketing; vigilance

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