About Us

Background of establishment

"Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association" (referred to as "the Association") was established to enhance the development level of Shanghai's medical device manufacturing industry and lead the high-quality coordinated development of the medical device industry in the Yangtze River Delta region. Under the guidance of the Shanghai Municipal Drug Administration, Shanghai Drug Administration Certification and Evaluation Center, and Shanghai Municipal Commission of Economy and Informatization, the Association was jointly initiated by the Medical Device International Cooperation Branch of China Medical Insurance Chamber of Commerce and industry-leading companies such as Roche Diagnostics, Siemens, Johnson & Johnson, Danaher, China National Pharmaceutical Group Co., Ltd.(Sinopharm), MicroPort, United Imaging, B. Braun, CACHET Pharmaceutical CO., LTD., Merit Medical, Fosun Diagnostics, Lingen Precision Medical Products (Shanghai) Co., Ltd., Lishengte Medical, DeYi technology, Zhiyi Health, and Fisher, to name a few. It also includes relevant industry organizations, KOLs, and academicians. The Association was established as an innovative industry organization in the context of implementing the "National Integrated Development Strategy of the Yangtze River Delta" proposed by General Secretary Xi Jinping. Since its establishment, under the guidance of government departments and with the active participation and support of its members, the Association has been working based on the principles of precision, professionalism, efficiency, and pragmatism. It is rooted in Shanghai and leads the development in the Yangtze River Delta region, actively carrying out various tasks. Via innovation in concepts, models, and services, the association continuously provides high-quality services to its members and promotes industry development. The Association is committed to promoting the rapid development of the advanced medical device manufacturing cluster, assisting international advanced medical device enterprises in establishing a presence in China, rooting in Shanghai, and serving the Yangtze River Delta region. It focuses on assisting the innovation-driven development of Shanghai's medical device industry, its integration into the global market, and the improvement of the industry's quality, safety, and compliance. The Association comprehensively promotes and advances the high-quality coordinated development of the medical device industry in the Yangtze River Delta region.

About the Association

Name of the Association: Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association (Abbreviated as "SDMDA" in English). 

Supervising Authority: Shanghai Municipal Commission of Economy and Informatization. 

Membership Composition: Domestic and international medical device manufacturing enterprises, research institutions, industry organizations, industrial parks, KOLs and academicians.

Main activities

The main activities carried out by the Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association (SDMDA) include:

To promote the healthy and orderly development of the industry, advocate for industry-related concerns, and provide professional guidance for standardized management, the association will carry out its work in the following areas:

1. Actively participating in national regulations and standards development

During the establishment and subsequent work of the Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association, close attention is paid to the development trends of the medical device industry. Based on the industry's needs and market dynamics, the association organizes industry experts to actively participate in the development of national medical device regulations. 

Under the commission of the National Medical Products Administration's Medical Device Supervision Department and the National Verification Center, the association took the lead in organizing the drafting of the "Good Manufacturing Practices for Medical Devices" (GMP) revision. 

In response to the work deployment of the Medical Device Registration Department of the National Medical Products Administration, the association participated in the drafting of the work plan for the "Management Regulations for Emergency Use of Medical Devices." 

At the request of the Shanghai Municipal Administration for Market Regulation, the association organized the drafting of the "Group Standard for Disposable Virus Sampling Tubes" and the "Group Standard for Disposable Sampling Swabs." In the future, the association will fully leverage the professional advantages of a new type of industry organization to actively support and participate in the development of national industrial policies, regulations, and related standards.

2. Establishing an integrated platform for communication and services: "One Exhibition, One Conference, One System"

To fully leverage the advantages of the advanced medical device manufacturing industry and talent cluster in the Yangtze River Delta region and accelerate the high-quality integrated development of the medical device industry in the region, the association will focus on creating brand platforms such as the "Yangtze River Delta Medical Device High-Quality Development Summit" and the "China·Shanghai Medical Device Innovation Exhibition Center." 

With a highly open attitude, the association aims to build an integrated platform for communication and services based on the concept of "One Exhibition, One Conference, One System." The association will also actively participate in and enhance the spillover effects of high-level professional exhibitions such as the China International Import Expo and the World Health Expo organized by the National Health Commission.

The association is actively promoting collaborative innovation and comprehensive strategic cooperation with universities and research institutions to better leverage their advantages in technology and industry. 

It aims to jointly build a leading domestic and world-class platform for innovation and technology transfer services. The association has already signed strategic cooperation agreements with Med-X Research Institute at Shanghai Jiao Tong University, the School of Intellectual Property at Tongji University, and the Shanghai Technology Exchange to promote the establishment of the Medical Device Technology Achievement Evaluation Center.

Through these efforts, the Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association aims to create a collaborative and innovative ecosystem, strengthen cooperation with academic and research institutions, and establish a world-class platform for innovation, technology transfer, and services in the medical device industry.

3. Strengthening the development of the medical device talent pool

The association places great importance on the development of a talent hub within the industry. 

It actively organizes and participates in the evaluation of professional titles for the "Quality Management Engineering" in the medical device field in Shanghai. This initiative aims to establish and broaden the career development path for professional technical talents in the medical device industry. 

The association collaborates extensively with various colleges and professional training institutions to construct a talent development system that meets the urgent needs of the industry at the senior, intermediate, and junior levels. 

Currently, it has partnered with Shanghai Health Medical College to design and develop professional training courses and curriculum for medical device management in non-engineering fields. It also collaborates with Shanghai Vocational College of Medicine and Health to promote the construction of the medical device discipline.

In the future, the association will develop and establish a medical device professional talent database. This database will serve as a platform for the industry and medical device manufacturing companies to recruit qualified talents, aiming to enhance the talent reserve level required for the high-quality coordinated development of the Yangtze River Delta region.

4. Work during the pandemic period

During the period of pandemic containment measures, the association has fully utilized its organizational resources and established a dedicated service team to listen to the demands of enterprises and assist in resolving their practical issues to the best of its ability. 

In response to concerns raised by enterprises regarding post-pandemic customs clearance facilitation and the optimization of the business environment, the association, in collaboration with the Shanghai Municipal Commission of Commerce, customs authorities, port and maritime authorities, as well as companies such as Yitong, organized an "Online Policy Promotion Conference for Cross-border Trade and Business Environment Reform." 

The conference disseminated and explained the preferential policies for stabilizing foreign trade, foreign investment, and promoting growth at the national and Shanghai city levels to every medical device enterprise. Nearly 400 institutions and individuals participated in the online policy interpretation.

In the post-pandemic period, the association actively coordinated with the Shanghai Municipal Commission of Commerce, the Shanghai Municipal Commission of Economy and Information Technology, and China Post to address various challenges faced by domestic and foreign-funded enterprises in the industry, particularly in logistics and supply chain management. Particularly, more than 20 practical difficulties were addressed through coordination and resolution.

In the future, the association will continue to serve as a bridge and service provider, addressing common issues encountered by industry enterprises through timely research and relief efforts. It will effectively provide services to enterprises, promote the active participation of medical equipment companies in industry system construction, and help them derive a sense of engagement and achievement. 

Additionally, the association will strengthen its connections with domestic and international industry organizations and academic institutions, promote international exchanges and cooperation, actively conduct industrial surveys and research, and provide professional and authoritative policy consulting services to industry enterprises.

The establishment of the Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association marks an important milestone in promoting the development and innovation-driven growth of the medical device industry. 

With the support and guidance of the municipal government and relevant departments, led by the first council, and with the strong support of all members, the association will undoubtedly help advanced international medical device companies establish themselves in China, take root in Shanghai, and serve the Yangtze River Delta region. 

It will assist the Shanghai medical device industry in driving innovation, expanding globally, and integrating into the global market. Efforts will be made to enhance the quality, safety, and compliant development of the Shanghai medical device industry. The association will comprehensively promote and facilitate the high-quality coordinated development of the medical device industry in the Yangtze River Delta region.

The Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association sincerely welcomes and invites your esteemed organization to collaborate, work together with industry colleagues, and jointly create a new type of service organization for the medical device industry.

Association Name: Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association (SDMDA)

Supervising Authority: Shanghai Municipal Commission of Economy and Informatization

Membership Composition: A professional non-government organization, voluntarily composed of domestic and foreign medical device manufacturing companies, research institutions, industry organizations, industrial parks, and KOLs and academicians.

Association Mission: To lead the development of China's medical device industry, empower innovation, and promote international cooperation.

Association Vision: To be a leader in the industry, a professional guide, and a comprehensive service provider.

Association Tasks: To promote the healthy and orderly development of the industry, advocate for common concerns in the industry, and provide professional guidance for compliance and integrity for enterprises.

Association Functions: Actively participate in the formulation of national policies and regulations, engage in international and domestic technical exchanges and cooperation, promote technological innovation and transformation in the medical device industry, and facilitate the high-quality coordinated development of the medical device industry in the Yangtze River Delta region.