Medical device vigilance system

  • Riya Patel Gujarat
  • Bhumika Maheriya Gujarat

Abstract

The medical device vigilance is the synchronized system of to identify, to compile, to notify and to analyse of any adverse event which are connected with the use of medical devices and to defend the health of   patient and also preventing relapses. In many nations, post-marketing surveillance of medical devices has begun but is not yet as established or robust as that for medicines. In USA a program has started under the name of Medical Device Reporting (MDR) and in 2015 India also introduced the Materiovigilance program by DCGI at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad. Main benefit of an efficient system such as medical device vigilance in reporting the risks and safety crises of medical devices has become gradually evident in recent years. Safety issues of medical devices tend to quickly gain global significance. The speed of information spreads in the modern world means that concerns about the safety of medical devices are no longer limited to individual countries. Around the world, to improve the standard of medical devices, several measures are being taken to provide greater patient safety. The main goal of the concept turns out to be to accurately ensure the safety of the patient, as well as provided that the necessary guidance for both producers and expert authorities that allows them to monitor cases reliably and appropriately.

Keywords: Materiovigilance, Medical Device Reporting (MDR), CDSCO, adverse event, surveillance, medical device

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Author Biography

Bhumika Maheriya, Gujarat

M.Pharm, PG Diploma in Intellectual property rights

Assistant professor at Graduate School of Pharmacy-Gujarat Technological University

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How to Cite
Patel, R., and Bhumika Maheriya. “Medical Device Vigilance System”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 1-8, doi:10.22270/ijdra.v9i3.475.