2017In December 2019, the Shanghai Food and Drug Administration issued and implemented the "China" (Shanghai )The Implementation Plan for the Pilot Work of the Medical Device Register System in the Free Trade Pilot Zone marks the official launch of the Medical Device Register System.Since then, the medical device industry has realized the understanding of the binding and the separation of the production and technical parties.
In order to make the science and technology park service team and medical device companies familiar with the business processes and work priorities of medical device registrants, and to provide more professional services to medical and industrial cross-border enterprises, solve problems for enterprises, and let the enterprises focus on R&D work.On July 14, 2020, Shanghai Science and Technology Park invited Professor Cheng Yunzhang, Vice Dean of the School of Medical Devices and Food of Shanghai University of Technology, to provide the park’s employees and enterprises with a "Thoughts on the Innovation Model of the Medical Device Industry"Carry out training。Through six aspects, including the origin of innovation, the development process of medical device product development process, the innovation process of the entire medical device industry, the new practice of the registrant system in Shanghai, and the thinking on the construction of the interdisciplinary medical and industrial cross-industry service platform, the development process of the entire medical device industry is systematically explained, and different industrial models at home and abroad are analyzed, so as to MAH Interpretation of the registrant system for actual cases in the pilot.
Professor Cheng Yunzhang, Vice Dean of the School of Medical Devices and Food, Shanghai University of Technology
Through this training, we can further understand the current development status of the medical device industry and the actual operation process of the Shanghai medical device registrant system, and provide professional advice for the park team and enterprises to apply for medical device registration certificates in the subsequent application.
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