MEDICAL DEVICE SAFETY AND SURVEILLANCE IN INDIA
Nilesh Mahajan, Dr. Anish Desai*, Reshmi Pillai, Dr. Sandeep Sewlikar,
ABSTRACT
Serious adverse events (SAEs) reported since 1989 compelled
investigators to find the cause and set the pace for development of
regulations for medical devices. This also included the incidence where
medical device failed to perform positively. Reporting of SAEs has
thereafter evolved in many nations and has taken shape as stringent
regulatory system in the name of “Pharmacovigilance”. This article
draws parallel attention to current scene in India and other developed
nations in reporting adverse event with respect to medical devices.
Keywords: Medical Device, Safety, Pharmacovigilance, SAEs.
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