Abstract

Millions of patient’s world widely depends on ever widening arrays of medical devices for the diagnosis, treatment and prevention and management of diseases. In Europe medical devices are regulated by European Commission and covered under New Approach of Directives. In Australia medical devices are regulated by Therapeutic Goods Administration (TGA) and in India it is regulated by central drugs standard control organizations (CDSCO). All these countries have slight different classification system and registration process for classifying and registering the medical devices in respected countries. This article mainly includes classification, registration process for approval, labeling requirements, adverse drug reaction reporting system and registration requirement for approval of medical devices in these three countries. This type of evaluation is helpful for newly developing industries for better understanding of all requirements as a regulatory point of view. Time duration limit for review of medical device registration fixed in Australia divergence to India regulation. Medical device registered for five year as per European and Australian regulation whereas in India only for three year. Application fees for registration of medical device in Australia and Europe seen costly as compared to Indian application fees.