Analysis of trends of clinical trials for medical devices registered under Clinical Trials Registry of India

INTRODUCTION India’s healthcare sector is expanding rapidly due to population growth, increased life expectancy, rising healthcare spending, government support, and improved infrastructure. The growth of telemedicine and medical tourism further enhances access and global engagement.[1] There are estimated 2 million different kinds of medical devices on the world market, categorized into >7000 generic device groups.[2] The industry is evolving through digital innovation, stricter regulations, and demand for real-world evidence. However, India continues to rely heavily on imports, nearly 70% of devices sourced internationally.[3] Despite a skilled workforce and advanced medical facilities, indigenous device manufacturing remains limited. This study analyzes trends in medical device clinical trials registered in India’s Clinical Trials Registry of India (CTRI) since 2007, aiming to inform policy, innovation, and investment while promoting technological advancement for improved clinical outcomes and cost-effective health care in the Indian ecosystem. MATERIALS AND METHODS This retrospective study, exempt from the Institutional Ethics Committee review, scrutinized CTRI-registered trials (July 2007–April 30, 2025) involving medical device. Utilizing keywords such “Medical device,” “Monitoring device,” “diagnostic device,” “therapeutic device,” “scopy,” “stent.” Five thousand three hundred and forty six results were initially retrieved. Three hundred and ninety seven clinical trials were included in the final analysis, as other studies were not done on medical devices. Data extraction encompassed year of study, study location in India, study designs (invasive or noninvasive), (academic or regulatory), and therapeutic area of medical device. Analysis was conducted using SPSS Version 21.0 (IBM Corporation, Armonk, New York, USA). RESULTS A total of 397 clinical trials involving medical devices were identified in the CTRI. Of these, 11.5% (n = 46) were conducted between 2007 and 2016, 30.7% (n = 122) from 2017 to 2020, and 53.9% (n = 214) between 2021 and 2024, indicating a steady rise over time. Institutional analysis showed that 70.7% (n = 281) of trials were conducted in private institutions, whereas 29.36% (n = 116) took place in government or centrally funded institutions. Regarding the nature of the devices, 65.8% (n = 261) of trials assessed noninvasive devices, whereas 34.12% (n = 136) focused on invasive devices. In terms of sponsorship and regulatory classification, 55.41% (n = 220) were regulatory trials sponsored by private companies, and 44.6% (n = 177) were academic studies. Geographically, trials were concentrated in Southern India, led by Karnataka (24%) and Tamil Nadu (9%). Northern India saw moderate activity, with New Delhi and Gujarat contributing 14% and 7%, respectively. Maharashtra in Central India accounted for 13.5% of trials, while Eastern India lagged significantly. Therapeutic area analysis revealed that anesthesia and intensive care comprised the largest share (23%, n = 91), followed by pediatrics (12.5%), general outpatient care (10.5%), and surgery/orthopedics (10%). These findings highlight evolving trends and imbalances in India’s medical device research landscape. DISCUSSION This study presents a comprehensive analysis of clinical trials involving medical devices registered in India’s CTRI from July 2007 to April 2025, showing a steady rise over 15 years. However, growth temporarily slowed during COVID-19 pandemic due to a global decline in non-COVID-19 research. Private institutions conducted over 70% of trials, likely benefiting from better funding, faster regulatory approvals, and stronger industry links. In contrast, government institutions were constrained by limited resources and bureaucratic delays, highlighting the need to strengthen public research infrastructure for equitable sectoral participation. Noninvasive devices featured in 65.8% of trials, reflecting regulatory ease and broader clinical utility. Over half the studies were regulatory in nature and sponsored by private firms, emphasizing strong commercial interest in validating devices for market approval. Geographically, Southern India dominated trial activity due to robust infrastructure and supportive policies. Eastern India was underrepresented, suggesting a need for targeted policy and capacity-building efforts. Anesthesia and intensive care accounted for the highest trial proportion, reflecting heightened demand for monitoring and life-support devices during and after pandemic.[4] To advance the medical device sector in India, it is essential to foster innovation, streamline regulatory pathways, and promote public–private collaboration.[5] Continuous oversight of device trials and future research on clinical outcomes and cost-effectiveness are critical to guide policy and deliver tangible health benefits. This study highlights a rising trend in medical device clinical trials in India, driven by regulatory reforms and national innovation initiatives. Strengthening local development, enhancing academia–industry partnerships, and ensuring regulatory clarity will be key to translating research into improved clinical outcomes and affordable health care. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.