Guorei Xinchuang Co-organizes the Central and Western China Medical Device Innovation and Development Conference.
Release time:
2023-07-01 11:56
Keywords:
0 June 29 -30th, The 2023 Central and Western China Medical Device Innovation and Development Conference was held at the Xi'an High-tech International Convention Center. The event brings together experts, scientists, engineers, and entrepreneurs from both inside and outside the industry to address various challenges and issues in the medical device sector, uncover and promote innovative achievements, and provide new insights for the future development of medical devices.
This conference is hosted by the Shaanxi Provincial Pharmaceutical Association and the Management Committee of the Xi'an High-Tech Industrial Development Zone. Shaanxi Province Medical Additive Manufacturing ( Organized by the 3D Printing Standardization Committee and the Xi'an High-Tech Enterprise Association ， Co-organized by Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. and other entities 。
Leaders attending the event included Feng Feng, Member of the Party Leadership Group and Deputy Director of the Shaanxi Provincial Drug Administration; Cheng Jin, Second-Level Researcher in the Medical Device Registration Division of the National Medical Products Administration; Jia Jianxiong, Head of the Comprehensive Business Department of the Medical Device Technical Review Center of the National Medical Products Administration; Yang Xiaofang, Deputy Secretary-General of the China Association for Medical Device Industry; and Yang Hua, Deputy Director of the Management Committee of the Xi'an High-tech Zone.
This conference invites Mao Zhenbin, former Director of the Science and Technology and International Cooperation Division of the National Medical Products Administration; Yu Xinhua, former Director of the Medical Device Standards Management Center of the National Medical Products Administration; and Cheng Jin, from the Medical Device Registration Division of the NMPA, each delivered presentations on topics including how regulatory science for medical devices can drive innovation and high-quality development of medical devices, pathways for participating in the formulation and revision of standards, and clinical trial management. Their presentations underscored how interpreting regulatory frameworks provides a solid foundation for fostering innovation. Cai Hu, Deputy Director of the Shaanxi Provincial Institute for Food and Drug Inspection; Professor Jin Yan from the Tissue Engineering Center of the Air Force Military Medical University; and Professor Cui Yali, a second-level professor at Northwest University—each an expert and scholar—subsequently shared their insights and offered recommendations based on their respective research fields, focusing on innovative development in the medical device sector.
The successful holding of the conference provided on-site guidance that truly integrated industry, academia, and research in various specialized fields of Shaanxi Province’s medical device industry, which is of great significance for promoting the healthy and rapid development of the medical device industry.
Co-organizing unit — Introduction to Guorui Xinchuang:
Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices. It was registered and established in June 2020 in the Airport New City Aviation Industry Park. Currently, it is a comprehensive medical device safety evaluation institution serving the Northwest region, primarily providing product safety evaluation services to R&D companies of Class II and Class III medical devices. Guorui Xinchuang has acquired advanced experimental equipment and instruments, including a Siemens DSA digital subtraction angiography system, a Youwo high-pressure injector for angiography, a Mindray respiratory anesthesia machine, and a Hutoo high-frequency electrosurgical unit. Since its laboratory was established, the company has invested nearly 20 million yuan. The successful completion of multiple batches of experiments has rapidly enhanced the laboratory’s domestic and international reputation and influence, solidifying its position as a domestic technology leader in preclinical large-animal studies for medical devices.
As an important intermediate link in the transformation of innovative medical devices from the innovation chain to the industrial chain, medical device safety evaluation research supports the interactive integration of the innovation and industrial chains in the life sciences sector under the Qin Chuang Yuan initiative, and holds significant value for the development of the province’s life sciences industry.
In March 2021, Guorui Xinchuang obtained the “License for the Use of Laboratory Animals” issued by the Shaanxi Provincial Department of Science and Technology. It is a preclinical evaluation laboratory for medical devices operating under GLP standards in our province. Currently, the company holds 6 software copyrights and was awarded the High-Tech Enterprise Certificate in October 2022.
※ Scope of business:
- For the National Medical Products Administration ( The Medical Device Technical Review Center of the NMPA provides preclinical animal studies and reports required for medical device registration.
- For the United States The FDA and the European Union (OECD) certify preclinical animal studies and reports that meet the regulatory requirements for medical device registration.
- We provide preclinical large-animal studies for the R&D phase of medical devices to innovative medical device companies, R&D institutions, and research institutes.
- Providing technical training and promotion services for the clinical application of medical devices to innovative medical device companies, R&D institutions, and hospitals.
- Establishment of various innovative animal models for basic research: experimental animal models for conditions such as myocardial infarction, heart failure, and fractures (including both large and small animals).
- Evaluation reports for medical device products or projects—covering government project support, investment fund consulting, and the initiation of R&D enterprise projects.
- In vitro simulation platform testing and reporting for medical devices during the R&D and registration phases.
- Clinical trial protocol development and consulting services based on physician teams and animal studies.
- Medical knowledge training and courseware development related to medical device R&D.
- Medical device testing and clinical new technology training based on ex vivo organs.
- Joint application for medical device R&D and innovation projects at the national, provincial, and park levels.
- Physician-led innovative design and industrialization services for patent commercialization.
- Product R&D Evaluation and Improvement & Optimization Report Based on Large Animal Studies.
※ Specific business scope:
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