MEDICAL DEVICE VIGILANCE MARKET ANALYSIS

Regional Analysis

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North America dominates the global medical device vigilance market with an estimated market share of 40.0% in 2025. The region enjoys the presence of many top medical device manufacturers who have their global headquarters located in the U.S. and Canada. Being an early adopter of digital health technologies, most large hospitals and healthcare systems in North America have well-established vigilance processes and reporting systems.. The region also has a highly developed pharmaceutical and medical devices industry that promotes high standards of vigilance to be followed. With significant healthcare expenditure and focus on patient safety, regulatory requirements in the U.S. and Canada ensure high levels of post-market surveillance for any adverse incidents with medical devices.

Asia Pacific region has emerged as the fastest growing market for medical device vigilance. Countries like China, Japan, India and South Korea are witnessing rising investments towards improving healthcare infrastructure and digital transformation of their health systems. This has positively impacted the growth of their vigilance capabilities. Presence of a huge patient population and rising disease incidence have  boosted the need for better vigilance of medical technologies. Many global medical device majors have also established manufacturing units in the Asia Pacific to cater to the growing demand, which has facilitated improved reporting of adverse events. The region is also home to a burgeoning local medical devices industry, with companies from China, Japan and India increasingly exporting their products globally as well. This help to build their competencies as well as regulatory requirements around post-market surveillance and vigilance. With healthcare undergoing significant change across Asia Pacific, investments in this area are expected to have strong momentum.