The development in science and technology has scaled multiple heights and reached unprecedented levels of sophistication. Advanced methods are being used in all branches of research and technology, including medical diagnosis. Given that diagnosis is done either voluntarily or pursuant to a prescription, the field of medical testing is broad and encompasses a variety of situations. The process of diagnosis depends upon a range of variables, which includes diversified procedures, competent personnel, functional instruments, suitable facility or lab, reagent, etc. Each factor is as important as the other. Further, medical devices include a gamut of instruments ranging from a miniscule syringe used to collect blood samples, to sophisticated CT scanners. Both have the capacity to grossly impact a diagnosis. Hence, arises the need to minimise the variables and ensure uniformity in quality and standards. And, while the monitoring of medical devices, facilities and competent personnel are largely regulated, it is important to ensure that the diagnostic procedures are standardised.Continue Reading Evolving Landscape of Diagnostics’ Regulation in India & Digital Healthcare
Aparajita Marwah
Associate in the Pharmaceutical, Healthcare & Life Sciences practice at the Delhi NCR office of Cyril Amarchand Mangaldas. Aparajita graduated from the National Law Institute University, Bhopal in 2022 and specializes in regulatory compliance, advisory work, tender matters and litigation pertaining to the pharmaceutical, medical devices, digital health, clinical trials and the life-sciences industry. She also has prior experience in project finance, general corporate and employment matters. She can be reached at aparajita.marwah@cyrilshroff.com