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The licensing of the international medical device intelligent manufacturing base in the bonded area

2022-11-23 17:008470

The international medical device intelligent manufacturing base in the bonded area of Shanghai Free Trade Zone, which is constructed by "one core and two zones", is expected to become an important growth pole of Pudong's biomedical manufacturing industry. As one of the important activities of the 2022 Shanghai International Biomedical Industry Week, the International Medical Device Intelligent Manufacturing base in the Bonded Area of Shanghai Free Trade Zone was officially awarded at the Third Waigaoqiao International Cooperation Summit Forum on Medical Health and the Future Development Summit Forum of the Medical Device Industry.


The base will be built into the first choice, hub and gathering place for international intelligent manufacturing of medical devices, strengthen functional superposition and ecological empowerment, serve to promote Pudong's medical and health industry to a new stage of high-quality development, and help Pudong build a world-class biomedical industry cluster.


At the forum, the launch of "6+3" major projects and the centralized signing of settled enterprises were also held. The enterprises participating in the project launch include Huiyong Pharmaceutical Research, a co construction unit of the National Engineering Research Center for Pharmaceutical Preparations, Kemixin Biology, a new generation of cell and gene therapy incubation platform, a leading enterprise in terms of lakeside biology, stem cells and gene therapy, Merck China, a one-stop solution provider for in vitro diagnosis, the world's largest medical laser equipment company, the medical laser technology innovation base Taoxuan Science focuses on the research and development of life science tools. The enterprises participating in the signing of key projects include Xihua Pharmaceutical, a service provider of innovative drugs and generic drugs with full life cycle integrated solutions, Weidu Bio, a high-tech biomedical enterprise serving life sciences and medical diagnostics, and Mingmai Education, the first medical device professional talent training institution in the city. The total investment and financing of the project is expected to exceed 1 billion yuan.


It is reported that relying on multiple institutional innovations in the leading zone, the free trade zone and the customs special supervision area, Waigaoqiao has attracted and cultivated 838 enterprises of various biological medicines and medical devices, with an operating income of 248.4 billion yuan in 2021 (including 213 medical supplies and equipment sales enterprises, with an operating income of 182.4 billion yuan and a tax revenue of 10.1 billion yuan), becoming the sea port for 27% of imported medical materials and drugs and 38% of imported medical devices nationwide.


Among the top 10 medical device enterprises in the world, 9 have invested and carried out business in bonded areas. After years of cultivation and construction, a group of leading enterprises in the biomedical industry have gathered in incubation, research and development, manufacturing, trade, logistics, distribution and other links.


In recent years, Waigaoqiao Group has continuously improved and optimized the "ecosystem" for the development of Waigaoqiao bio pharmaceutical industry with a 2 square kilometer characteristic industrial park as the carrier. "Relying on the unique advantages of" Free Trade Zone+Bonded Zone ", the innovative measures of investment and trade facilitation have attracted more and more leading medical device enterprises to choose the bonded area of Shanghai Free Trade Zone for localized production and mass production." Yu Yong, Chairman of Waigaoqiao Group, said.


For example, depending on the registered holder system, enterprises in the bonded area, such as Xerox, Flextronics and Fresenius, have deep cooperation to improve the efficiency of industrial division. The R&D platform, distribution center, assembly factory, digital base, etc. form a collective force to help the local manufacturing of medical devices develop rapidly and upgrade to high-end intelligent manufacturing.


At the meeting, Ding Sheng, General Manager of the Development Strategy Department of Waigaoqiao Group, introduced the international medical device intelligent manufacturing base in detail, which is divided into "one core and two zones" in terms of spatial planning. The "one core" core area is located in the approved Waigaoqiao Biomedical Industrial Park with an area of 2 square kilometers, including the i-SPACE Bonded Area International Medical Device Exhibition and Trading Center, U-Lab Biomedical Sharing Laboratory, the Great Health Innovation Park, the Life Science Park, and the New Exhibition City Industrial Community Zimao No.1 Life Science Park. The "two zones" are respectively located in the Waigaoqiao Port Comprehensive Bonded Zone and Pudong Airport Comprehensive Bonded Zone, with an overall planning area of about 1 square kilometers.


According to the base construction plan, we will strive to create an industrial cluster space of nearly one million square meters by 2025, and attract more than 100 key enterprises in the field of trade, research and development, production, scientific and technological services and other intelligent manufacturing of medical devices by 2030.


It was learned at the meeting that Waigaoqiao Group established a coordination channel with the competent industry departments and the functional departments in the district, worked together to win support for enterprises in medical device access, review, supervision, etc., promoted the implementation of policy support for characteristic parks in Shanghai, and helped enterprises strengthen the protection of relevant intellectual property rights. At the same time, we will introduce Shanghai Biomedical Product Registration Guidance Service Workstation, build a "city district park" intercommunication platform, form a policy toolbox and special support funds for the medical device manufacturing industry in the bonded area, focus on the registration and implementation of medical device products, promote the guarantee of direct access to the park and close to enterprises, promote the rapid transformation of industrial achievements, and provide a springboard for the localization of imported medical devices, local manufacturing and export overseas.


In the future, Waigaoqiao Group will combine the characteristic advantages of the bonded area of the Free Trade Zone to promote the "three overlapping" of trade, distribution and R&D, and the "three empowerment" of bonded, space and environment, further serve to build an ecosystem and cluster highland, and accelerate the formation of the "smart brand" of the bonded area, the "smart service highland" of production and smart manufacturing, the "smart space" of medical devices, and the innovative development of the "ecological rainforest", We will comprehensively promote the transformation and upgrading of bonded areas, and create a preferred place for trade and investment, a hub for functional interaction, and a gathering place for factor resources for market segments.


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