Guorei Xinchuang has achieved zero-defect status and successfully passed the OECD GLP assessment, earning the corresponding certification.

From July 12 to July 14, 2025, GLP inspectors from the Organization for Economic Co-operation and Development (OECD) conducted a three-day on-site GLP inspection of Shaanxi Guorei Xinchuang Medical Technology Co., Ltd.

Guo Rui Xin Chuang Zero defects Through OECD GLP Review and obtain the certification certificate

2025 Year 07 Moon 12 Date to 07 Moon 14 Day, the Organisation for Economic Co-operation and Development ( Organisation for Economic Co-operation and Development, OECD ) GLP The inspector examined Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. (hereinafter referred to as... “ Guo Rui Xin Chuang ” ) Implemented for a period of 3 of the sky GLP On-site inspection, Guorui Xinchuang with Zero defects Successfully passed the on-site inspection. 

Guo Rui Xin Chuang Yu 2025 Year 10 Moon 15 Received on the day OECD GLP Certification certificate; the scope of this certification includes: 

1. Analytical Chemistry and Clinical Chemistry Testing: Analysis of biological samples, pesticide residue analysis, veterinary clinical pathology (clinical laboratory testing); animal biological samples include: blood samples, body fluid samples, and organ tissue samples. 

Analytical chemistry and clinical chemistry testing: biological sample analysis, pesticide residue analysis, veterinary clinical pathology (clinical testing and detection), animal biological samples including: blood samples, body fluid samples, and organ tissue samples; 

2. Veterinary Histopathology: Non-clinical safety and efficacy pathological evaluation, pathological studies and diagnosis of animal diseases, etc. ;

Veterinary histopathology: Non-clinical pathological evaluation of safety and efficacy, pathological research and diagnosis of animal diseases, etc.;

3. Medical devices. 

Medical Device ： Biological evaluation (tests for systemic toxicity, tests for irritation and skin sensitization, tests for genotoxicity, tests for reproductive toxicity, tests for carcinogenicity, tests for local effects after implantation, tests for interactions with blood, etc).

OECD The expert panel representatives conducted a comprehensive and meticulous inspection of our company’s organizational management and personnel, laboratory facilities, instruments and equipment, computerized systems, experimental materials, standard operating procedures, quality assurance system, trial operations, and documentation archives. They also sampled multiple items for compliance. OECD GLP The standardized test underwent a comprehensive traceability review, and the review results were compliant. GLP Requirement.

This time GLP Authentication Check OECD The expert panel on our company GLP The system received full recognition, and the expert panel especially extended warm congratulations on our company’s inspection results, praising our company’s hardware and software facilities, quality management system, and the technical capabilities of our personnel. GLP Consciousness fully acknowledges it.

Guo Rui Xin Chuang has successfully obtained... OECD GLP Certification means that the institution’s test data are globally accessible, including in the United States, Europe, Japan, Australia, Canada, and other regions. OECD Member states and Mad Comply with national recognition and achieve. “ International interoperability ” This has provided Guorei Xin Chuang with a broader platform in the medical device sector.   Currently, Guorui Xinchuang's medical devices GLP The quality system has reached a new milestone and fully meets internationally recognized standards, enabling it to satisfy the registration requirements of different countries and regions and helping products enter the international market swiftly.

Guorui Xinchuang is committed to promoting development in Shaanxi Province and throughout China. GLP Development, according to China NMPA GLP China Accreditation Body CNAS GLP and the OECD OECD GLP We are required to operate and manage the laboratory and provide groundbreaking research services for medical device products. Guorui Xinchuang will also continue to share resources across multiple fields. GLP By leveraging advanced management concepts and practical experience, we will serve China—and indeed the global community—more efficiently and with higher quality in registration and application processes. At the same time, we will continuously enhance our cutting-edge technology systems, sustainably develop and build a world-class, high-end platform, and cultivate more professionals with an international perspective. This will lay a solid foundation for achieving higher levels of development and ultimately benefit human health. 

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, established in... 2020 Year 06 Yue was registered and established in Kongxin New City. It is currently a comprehensive medical device safety evaluation institution in the northwest region, primarily providing product safety evaluation services to R&D companies of Class II and Class III medical devices. Guorui Xinchuang has already purchased Siemens equipment. DSA Experimental equipment and instruments, including digital subtraction angiography machines, Youwo high-pressure injectors for angiography, Mindray respiratory anesthesia machines, and Huetong high-frequency electrosurgical units. Since the laboratory’s establishment, nearly... has been invested. 2000 With the completion of multiple batches of trials, the laboratory has rapidly enhanced its national and international reputation and influence, solidifying its position as a domestic 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 bridges the interaction and integration between the innovation chain and the industrial chain in the life sciences sector under the Qin Chuang Yuan initiative, and thus holds significant value for the development of the province’s life sciences industry. 

Guo Rui Xin Chuang Yu 2021 Year 03 The license for the use of laboratory animals, issued by the Shaanxi Provincial Department of Science and Technology, makes us the only entity in our province to comply with... GLP Preclinical evaluation laboratory for medical devices in operation. At 2022 Year 07 The company has been awarded the National High-Tech Enterprise Certificate and currently holds 6 The computer software copyright application is currently being submitted. 3 One patent.

Guorui Xin’s business scope: 

1. For the National Medical Products Administration ( NMPA The Medical Device Technical Review Center provides preclinical animal studies and reports required for medical device registration. 

2. For the United States FDA and the European Union ( OECD ) The certification provides preclinical animal studies and reports required for medical device registration. 

3. 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. 

4. Providing technical training and promotion services for the clinical application of medical devices to innovative medical device companies, R&D institutions, and hospitals. 

5. 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). 

6. Evaluation reports for medical device products or projects—covering government project support, investment fund consulting, and the initiation of R&D enterprise projects. 

7. In vitro simulation platform testing and reporting for medical devices during the R&D and registration phases. 

8. Clinical trial protocol development and consulting services based on physician teams and animal studies. 

9. Medical knowledge training and courseware development related to medical device R&D. 

10. Medical device testing and clinical new technology training based on ex vivo organs. 

11. Joint application for medical device R&D and innovation projects at the national, provincial, and park levels. 

12. Physician-led innovative design and industrialization services for patent commercialization. 

13. Product R&D Evaluation and Improvement & Optimization Report Based on Large Animal Studies.

OECD GLP Introduction 

Organisation for Economic Co-operation and Development (OECD) Organisation for Economic Co-operation and Development, OECD ), abbreviated as OECD, was established in 1961 The organization, headquartered in Paris, is an intergovernmental international economic organization composed of multiple member countries including the United States, France, the United Kingdom, Germany, and others. 

Based on the scientific and practical experience of various countries, the OECD Principles of Good Laboratory Practice have been established. OECD GLP ), applicable to non-clinical safety studies of substances contained in pharmaceuticals, medical devices, pesticides, cosmetics, veterinary drugs, as well as food additives, feed additives, and industrial chemicals. As a mature quality control mechanism, this... GLP Regulations help ensure the high quality and reliability of testing data, thereby forming the foundation for mutual recognition of data among countries. By avoiding redundant testing, these regulations prevent unnecessary waste for governments and enterprises worldwide while also contributing to the protection of human health and the environment.