After Covid-19 pandemic the healthcare sector is witnessing an exponential growth around the world. The innovations in medical electronics has armoured the existing healthcare infrastructure in diverse dimensions such as digitizing medical test, diagnostic and therapeutic procedures. Further, invent of nanotechnology have given new multidimensional paradigms to this sector. The fast pace growth in this domain requires bringing doctors, experts from technology providing industries, key decision makers from various government bodies, academician and other stake holders at a common platform. Indian health care industry presents a heterogeneous scenario; on one hand we provide state of the art facilities at health centres but on the other hand there is a section of population that struggles for basic healthcare needs. In this situation it becomes imperative to provide an affordable and easily accessible diagnostics and/or theranostics systems with precision and accuracy. Increase in the prevalence of diseases, their complexity and the need for quick diagnosis has created high demand for diagnostic services and devices in the country. Furthermore, with the growing size of medical equipment market, the quality control becomes a challenging issue.
Dr Kotnala had established a national facility for standards in biomedical instrumentation with traceability to physical parameters and formulation of proper documentation with specific regulatory bodies to maintain the quality service in biomedical arena. There is no defined regulatory framework for the Indian Medical devices industry. Ministry of Health and Family Welfare (MoHFW), Drug Controller General India (DCGI), Bureau of Indian Standards (BIS) and Atomic Energy Regulatory Board (AERB) regulate various aspects of the medical electronics sector. However, “Medical Devices” have no separate regulatory status in India, and CDSCO (Central Drugs Standard Control Organization) is principally responsible for its regulation. Medical Devices are high on innovation. India is becoming world’s preferred medical tourism place therefore defining appropriate framework for standard and calibration of medical instruments becomes imperative.
Established calibration and testing facilities of defibrillator with traceability to CSIR-NPL
Magnetic Field (Traceable to NPL standards) on site calibration using NMR Gauss meter (Frequency)