Overcoming Globalization Challenges: The 2023 Inaugural Digital Health International Exchange Summit and Digital Medical Products Going Global Forum

Looking outward, despite the myriad uncertainties in the current global macroeconomic environment—such as geopolitical risks, slowing economic growth, and supply chain disruptions—going global remains an inevitable trend for China’s leading medical technology enterprises. The normalization of global trade exchanges, the technological and capital accumulation achieved through domestic substitution in the home market, investors’ demand for growth, and companies’ pursuit of broader overseas markets are all driving an increasing number of Chinese medtech firms to proactively step onto the international stage to achieve substantial development.

Looking inward, the 20th National Congress of the Communist Party of China proposed accelerating the development of the digital economy and promoting its deep integration with the real economy. As a vital component of the digital economy, digital health encompasses numerous medical and healthcare fields closely related to public healthcare access and well-being, including digital therapeutics, digital diagnostics, and digital rehabilitation and wellness. Thus, 2023 will mark the beginning of a new chapter in the rapid international expansion of China’s digital healthcare industry.

To further promote the globalization of the digital health industry and align consensus within China’s digital health sector, to drive widespread practice and collaborative value creation in digital medicine, and—drawing on a global perspective and China’s national context—to comprehensively understand and deeply grasp international trends, academic frontiers, industrial trajectories, and overseas expansion policies in the digital medicine sector, thereby achieving standardized, high-quality, and sustainable development of China’s digital medicine industry and establishing a truly effective platform for exchange and discussion that fosters the advancement of digital medicine. The Digital Therapeutics Professional Committee of the China Association of Medical Device Industry,Shanghai Institute for Medical Device Testing,Organized by Sinopharm-Reed Exhibitions, with Viatris Pharmaceuticals Co., Ltd., VCBeat, and VB100 as co-organizers, the “Inaugural International Summit on Digital Health Exchange and Forum on Going Global for Digital Medical Products” (hereinafter referred to as the “Forum”) is scheduled to be held in Shanghai on May 16, 2023 (during the Spring 2023 CMEF).

This forum will focus on discussions regarding the global regulatory registration, review, and approval of digital health products, brand commercialization strategies, and industrial implementation, aiming to address the key challenges and pain points faced by Chinese digital health companies in achieving global market access.

As the global pandemic becomes a chapter of history, the relatively mature overseas digital health market has once again become the primary focus for Chinese companies, with Chinese enterprises and products converging to break through on the global stage. Beyond traditional European and American markets, forward-looking healthcare companies are extending their reach to emerging markets, particularly in the Middle East. While many industries were impacted by the COVID-19 pandemic, Chinese healthcare companies secured a significant volume of overseas orders. However, although emerging markets such as the Middle East and Africa offer substantial opportunities, successful market entry cannot be achieved overnight.

The medical device market, to which digital health belongs, is a strategic industry characterized by multidisciplinary integration, knowledge intensity, and high value-added. It features high barriers to entry and serves as an indicator of a country’s manufacturing and technological prowess. Across all countries and regions, the medical device market is subject to stringent regulatory approval systems. Some Middle Eastern nations, despite being less developed than China, maintain even stricter medical regulations. For instance, countries such as Turkey and the United Arab Emirates have adopted regulatory frameworks aligned with those of the U.S. Food and Drug Administration (FDA).

For medical enterprises targeting emerging markets, ensuring product safety and efficacy while maintaining regulatory compliance forms the foundational basis for successful global expansion. After obtaining domestic registration certification, securing market access approvals from the United States or the European Union first enables broader international recognition, demonstrating endorsement by the world’s most stringent regulatory authorities. Furthermore, the critical next step involves obtaining Certificates of Free Sale (CFS) in these key jurisdictions; achieving multi-regional global registrations signifies that the enterprise has overcome significant challenges and entered a new phase of development. Consequently, proactive systematic planning for international expansion, enhancing execution efficiency, controlling costs, building brand operations, and differentiating products and commercialization strategies amid homogeneous competition are all vital considerations.

To this end, the forum has invited compliance experts in digital health products from China and abroad, as well as representatives from investment institutions and enterprises, to gather and explore pathways for transforming the digital health industry and breaking through barriers in overseas innovation, with a focus on key emerging markets such as the Middle East.

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For details on conference cooperation, please contact the Organizing Committee: Mr./Ms. Liu (Tel: 15840063680)

For registration inquiries, please contact the Organizing Committee: Mr./Ms. Weng(Contact Number: 15922837745)