Regulation and Health technology assessment of Medical Devices in India
Current Situation, Challenges and International Experiences
Siddesh Shetty, Shankar Prinja
India is one of the largest emerging markets for medical devices. It is estimated that there are over 6000 different types
of medical devices in India. The regulatory framework governing medical devices in India has traditionally been limited. Until 2017, all medical devices except for a select few categories were largely regulated as drugs.
Medical Device Rules, 2017 for the first time defined medical devices, classified them into risk based categories, streamlined online processes, reformed licensing provisions, identified clinical trial compliance requirements and set an governing frame for regulation of medical devices in India. Similarly, price control mechanisms were notified in 2020 under the Drugs Price Control Order, 2013 by applying provisions in place for drugs to set pricing for medical devices. In this period, India has also begun institutionalization of Health Technology Assessment (HTA) as a decision-making tool to help prioritization of resources to achieve the aim of Universal Health Coverage. HTA as a tool systematically analyses costs and consequences of healthcare interventions using evidence informed approach with consideration for social and ethical concerns in informing efficient and equitable decisions.
For rapidly evolving medical device space in India and its impact, ensuring safe, effective, quality and affordable medical devices in diverse Indian settings through robust adaptive policies that safeguard people’s rights are critically essential. Indian medical device policies currently are at an evolving stage. India can learn from health system experiences from across the world to judiciously plan and implement the best fitting strategies for its contextual settings. This study aimed at identifying and reporting such practices to bridge the knowledge gap for commonly faced challenges and innovative solutions recognized in policy implementation across systems.