India Contemplating More Local Testing of Medical Devices

The Indian CDSCO is now discussing the need to test more devices locally to obtain Indian device approval. Recently, a task force has been established to determine what needs to be done to increase India’s testing facilities. Various categories of medical devices may need different types of tests. Currently, only a few devices require local testing in India whereas almost all IVDs need local testing for approval. The device industry is combatting this potential change claiming that their imported products have already been tested and approved overseas. The device industry is now pushing the government to increase testing labs only for local Indian device manufacturers who do not have in-house capabilities. These regulations are still in process and not officially issued yet.