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Materiovigilance

  • Maneesh Soni,
  • Mukesh Nandave,
  • Anoop Kumar

摘要

Materiovigilance is a coordinated system for identifying, gathering, reporting, and analysing any untoward incidents associated with the use of medical devices, the goal of protecting patients’ health by reducing the likelihood that they will occur again. Medical device post-marketing surveillance has been started in many nations, but it is still not as advanced and reliable as that for medicines. The current state of Materiovigilance is examined, along with comparisons to developed nations, gaps are noted, and specific actions are suggested to strengthen the programme. The meaning of Materiovigilance (Mv) is safeguarding the use of medical devices must be made clear to consumers and health professionals, who should also become aware regarding the reporting processes and emergency preparations of medical device-related adverse event. This chapter contains the brief information regarding post-marketing surveillance system of medical devices and regulation of medical devices in India and in other countries.