A symposium on exchanges between Chinese and foreign medical device enterprises was successfully held in Beijing

On December 12, the "China-Foreign Medical Device Enterprise Exchange Roundtable," hosted by the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE), was successfully held in Beijing. Vice President Meng Dongping, Vice Director Wang Shucai of the Medical Device Supervision Department of the National Medical Products Administration (NMPA), and Director Lin Senyong of the Medical Device Supervision Office of the Shanghai Municipal Drug Administration attended the meeting and delivered speeches. The meeting invited more than 40 representatives from 23 domestic and foreign medical device companies, including the Shanghai Medical Device Industry Association, Guoyao Medical Devices, United Imaging Healthcare, Mindray, GE, Philips, Siemens, Johnson & Johnson, Medtronic, Abbott, Olympus, B. Braun, and Varian.

Meeting Scene

Vice President Meng Dongping delivered the opening remarks. She pointed out that in recent years, China's medical device industry has shown rapid development, with increasing market demand and significantly enhanced international competitiveness. A sustained growth rate of 20% for over a decade demonstrates the industry's vitality and resilience. At the two China International Import Expos (CIIE), medical devices were a significant element in the highly-regarded medical and healthcare exhibition area, with multinational and leading companies from around the world showcasing advanced medical products and technologies. The "Pharmaceutical and Medical Device Regulatory Exchange Series of Activities," co-hosted by the NMPA and the CIIE Bureau and undertaken by the CCCMHPIE, attracted numerous domestic and foreign companies, demonstrating the immense appeal of the Chinese market and the unprecedented opportunities it offers globally. Currently, the Chamber is committed to building high-quality platforms to promote the international development of pharmaceutical and health products. In particular, the country's increased efforts in medical and health reforms in recent years, along with a series of positive policy measures, have provided institutional safeguards for industry development. Implementing the central government's overall requirements for promoting high-quality economic development, providing policy and industry services through the establishment of authoritative, precise, and professional platforms is a crucial task for the CCCMHPIE at this stage. The Chamber's work has received attention and support from the NMPA, the Shanghai Municipal Drug Administration, and various other parties. Currently, plans are underway to promote specific work, and we hope that everyone will cooperate and work together to contribute ideas and suggestions for building a scientific medical regulatory system and jointly promote the healthy and sustainable development of China's medical device industry.

Vice President Meng Dongping's Speech

Vice Director Wang Shucai spoke positively about the role played by the Chamber during the second CIIE, expressing gratitude for the Chamber's long-standing support for drug regulatory work, particularly in providing this opportunity for domestic and international enterprise exchange. Director Wang emphasized that this year marks the second year of reform of the national drug regulatory system and is a year for revising laws and regulations. The "Pharmaceutical Law" and "Vaccine Management Law" have been promulgated and implemented, and the "Regulations on the Supervision and Administration of Medical Devices" is expected to be released soon. He detailed the policy direction and work to be carried out in 2020 regarding medical device regulatory system reform, including: the medical device registrant system, the implementation of unique identification for medical devices, comprehensive regulation of online sales through a network monitoring platform, further strengthening risk management of medical device operation and use, conducting targeted inspections, and strengthening enterprises' self-inspection capabilities and training. He stated that strict post-market supervision, serious handling and punishment of illegal and irregular behavior, and research and traceability of clinical use data will all become key areas of work. He hopes that the CCCMHPIE will further leverage its platform role and influence, strengthen policy publicity and provide reasonable guidance; strengthen cooperation with relevant institutions, associations, and enterprises, and broadly gather strength to promote the construction of a medical quality supervision system, using high-quality supervision and high-quality products and services to promote high-quality industry development, improve medical standards, and benefit the people.

Speech by Vice Director Wang Shucai of the Medical Device Supervision Department of the NMPA

Director Lin Senyong of the Medical Device Supervision Office of the Shanghai Municipal Drug Administration spoke highly of the achievements of the CCCMHPIE in promoting international exchange and cooperation in the industry, particularly in the organization of related work for the CIIE. He stated that China's medical device industry is playing an increasingly important role in the country's economic development. The size of the greater health industry in 2020 will reach 8 trillion yuan, and 16 trillion yuan in 2030, accounting for 10%-12% of GDP, approaching the level of developed countries, with increasingly good market prospects. Director Lin pointed out that the core idea of this year's regulatory revisions is the registrant management system, establishing a scientific regulatory system, and gradually aligning with international standards. Enterprises need to adapt to changes in regulations as soon as possible. He introduced the achievements of Shanghai's pilot program on the registrant management system. Shanghai is an important region in the Yangtze River Delta for importing and producing medical devices and has always been at the forefront in implementing the system. He hopes that through the CCCMHPIE's establishment of a practical and effective platform for exchange between domestic and foreign enterprises, suggestions can be provided for the formulation of relevant national regulations and policies, and attention can be given to solving the practical problems of enterprises.

Speech by Director Lin Senyong of the Medical Device Supervision Office of the Shanghai Municipal Drug Administration

Subsequently, Deputy Director Ren Fang of the Medical Device Department of the Chamber introduced the development of China's medical device foreign trade and the Chamber's work. In the final free discussion session of the meeting, representatives from the Shanghai Medical Device Industry Association, Abbott, Philips, Johnson & Johnson, GE, Medtronic, Jabil, Guoyao Medical Devices, United Imaging Healthcare, and Mindray, discussed issues such as the innovative development and globalization trend of the medical device industry, the opportunities and challenges brought about by the rapid changes in China's medical device policies and regulations, and how to fully leverage the role of industry organizations and third-party social forces to promote integrated industry development with the attending leaders.

Representatives from GE, Johnson & Johnson, Philips, Abbott, Medtronic, United Imaging Healthcare, Mindray, and Pan Pacific expressed that the reform and innovation of China's medical and health regulatory system has greatly benefited enterprises. They hope that in the future, through the third-party platform built by the Chamber, they can closely connect enterprises and the government and play a greater role in providing advice and suggestions. Many called for the establishment of a specialized industry organization to serve as an important platform for strengthening communication between medical device companies and the government. They suggested increasing training for professionals on specific regulations and products in the context of new policies, which is also an important way for the industry to participate in the formulation of regulations.

Representatives from Enterprises Speaking

Vice President Meng Dongping stated that the CCCMHPIE appreciates the trust and support of the NMPA, the Shanghai Municipal Drug Administration, and numerous enterprises and institutions. Under the guidance of the government, the Chamber is willing to actively integrate resources, form a united force, and build bridges for the formulation and implementation of national policies and communication between domestic and foreign entities. By providing professional technical support, the Chamber will help enterprises and the industry solve problems encountered in their development and correctly and properly guide the healthy and sustainable development of the industry.

Vice Director Wang Shucai finally stated that the CCCMHPIE is able to bring together multiple resources and has the strength and ability to promote international cooperation, coordinate import and export policies, promote trade cooperation, and serve the needs of enterprises. He hopes that through the establishment of the Chamber's platform, comprehensive services can be provided for industry development, and the construction of a strong pharmaceutical quality supervision system can be jointly promoted. Members of the Business Coordination Department attended the meeting.

On-site Exchange Among Attendees

Group Photo of Some Attendees