ABSTRACT

The Chinese government has been actively investing to upgrade China medical device innovation and manufacturing to advance public health in China, accelerate “made in China 2025” and “Healthy China 2030,” while controlling the cost of healthcare with access and affordability. Medtech companies can lead in the new normal with agility by accelerating digital transformation, across the product life cycle to accelerate new business model, shorten time-to-market, improve top- and bottom-line with operational efficiency, enable digital supply chain and post-market surveillance. Medical technology regulatory systems aim to protect and advance public health and safety while support innovation and access. Public trust and confidence in these systems depend on the safety and performance of medical devices throughout the product life cycle. Digitalization facilitates real-time data across the product life cycle and post-market usage, which provides a closed loop for continuous quality improvement, which benefits patients and supports national health initiatives.