Center Introduction

Shanghai Biomaterials Research and Testing Center (referred to as "the Center") was established in June 1989 with approval from the Shanghai Municipal Science and Technology Commission [Document No. Hu Ke (89) 134]. It is affiliated with the Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The Center specializes in biocompatibility testing, evaluation, and standardization research for medical devices and biomaterials (including dental materials). As one of China's earliest institutions to establish biological evaluation and testing methods for biomaterials, the Center is a reputable "third-party" service organization both domestically and internationally, with academic standing and first-class testing capabilities. The Center holds accreditations from National Medical Products Administration (NMPA), China Metrology Accreditation (CMA), China National Accreditation Service for Conformity Assessment (CNAS). It complies with the ISO/IEC 17025 standard "General Requirements for the Competence of Testing and Calibration Laboratories". In the field of biological evaluation of medical device/biomaterials, the Center not only possesses testing capabilities aligned with Chinese national standards and industry standards, but also leads the industry in adopting ISO and other international standards, with technical competencies fully meeting global benchmarks. The Center is authorized to issue legally valid medical device registration test reports and Chinese-English Bilingual Testing & Evaluation Report for domestic and international clients. Leveraging the technical expertise of its affiliated university and hospital, the Center is equipped with advanced testing instruments and a team of highly qualified professionals. To meet the evolving demands of the medical device industry, it has developed capabilities to support innovative medical device testing and established a comprehensive platform offering research, testing, and consulting services to global clients.