In a bid to ensure the quality and safety of medical devices and IVDs, the Drugs Controller General of India (DCGI) has mandated compliance with Bureau of Indian Standards (BIS) for product testing. This move aims to address concerns about the use of untested or substandard medical devices, which pose health risks. Despite the directive, challenges remain due to the limited availability of BIS standards for the wide range of devices used in India. However, the Ministry of Health has authorized the use of Medical Device Rules (MDR) standards when BIS standards are unavailable.