Title:Materiovigilance as a Health Care Safety in India: A Regulatory Prospective
Volume: 2
Author(s): Vaishali Gutte, Shoaeb Mohammad Syed*Wajed Chaus
Affiliation:
- Department of Pharmaceutics, Dayanand College of Pharmacy, Latur MS 413512, India
Keywords:
Materiovigilance, Medical device, MvPI, Post marketing, Adverse Events, Health care safety.
Abstract:
Over the past few centuries, life-saving tools have been extensively used across the globe. The use of medical devices has increased adverse events
associated with them. Materiovigilance is the process of identifying, collecting, reporting, and examining unfavorable events connected to medical
devices in order to prevent the recurrence of such occurrences. Several countries keep an eye on medical products once they are commercialized.
Other nations with similar programs include France, Australia, and the United Kingdom, in addition to the Medical Device Reporting (MDR)
programme in the United States. This article addressed how some types of medical equipment might be dangerous and how a Materiovigilance
programme is essential.
This page provides information about how to report adverse reactions to these medical devices, as well as what they are.
In many countries, post-marketing surveillance for medications has been initiated but is not as reliable and advanced as it is today. By monitoring
adverse events related to medical devices, generating safety data, educating stakeholders, and recommending appropriate procedures and
interventions, the Indian Pharmacopeia Commission established the committee on July 6, 2015.
Monitoring adverse events related to medical device usage can increase patient safety. On the basis of safety data gathered and generated, the
Central Drugs Standard Control Organization (CDSCO) will make recommendations about the safe use of medical devices in the Indian
population.
