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.