History

Started to research and establish the performance test methods for dental materials, and provided testing services for Shanghai Dental Materials Factory and other units.

Started research and establishment of testing methods for biological properties of biomaterials (one of the first units in the country).

The Shanghai Biomaterials Research and Testing Center (referred to as the Center) was approved by the Shanghai Municipal Science and Technology Commission and established in June 1989. The Center's predecessor is the Dental Materials Research Laboratory of Shanghai Second Medical University, founded in 1960, and the Biomedical Materials Research Laboratory of Shanghai Second Medical University, founded in 1982. The Center focuses on conducting biological performance testing and evaluation, biocompatibility research, and standardization research on medical devices (including oral equipment) and biomaterials. The Center is one of the earliest institutions in China to establish biological evaluation and testing methods for biomaterials. It is a reputable and academically renowned third-party service organization with first-class testing capabilities both domestically and internationally.

Participated in the methodological research of the "Evaluation Standard for Biological Properties of Dental Base Materials" (as the drafting unit for the deputy group leader).

Participated in the methodological research of "Medical Heat Vulcanized Methyl Vinyl Silicone Rubber WS5-1-87" (as the drafting unit for the deputy group leader).

Assisted the "Jinan Center of the National Medical Products Administration" in establishing a testing program for "Biological Evaluation."

Participated in the initiation of the "Test Methods for Biological Evaluation of Medical Silicone Materials GB/T16175-1996" and was the primary drafting unit.

As a drafting unit, participated in drafting the "Technical Requirements for Biological Evaluation of Biomaterials and Medical Devices: Wei Yao Fa [1997] No. 81"; Participated in the research on "Technical Requirements for Clinical Studies of Biomaterials and Medical Devices" and was also a drafting unit.

Co-editor and member of the editorial board of the "Series of Propaganda and Training Materials on Biological Evaluation of Medical Devices"; In 1999, passed the assessment of the Municipal Administration of Quality and Technology Supervision and obtained the qualification (CMA) for the "Biological Evaluation and Testing" project.

Signed a subcontract agreement with the "Shanghai Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration" to undertake tests related to the biological evaluation of medical devices.

Obtained the "China National Accreditation Service for Laboratories (CNAL) Accreditation Certificate"; In 2006, received qualification recognition from the State Food and Drug Administration (SFDA).