Shanghai: medical device registration certificate approved for the first scientific research institution in the country

  • 2019-01-18

The first medical device registration certificate of “customized additive manufacturing knee orthosis” applied for by a scientific research institution was issued yesterday. The product was the scientific achievement of clinical research transfer, developed by the team led by academician Dai Kerong and director Wang Jinwu in Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University (SJTU) School of Medicine, applied for by SJTU Intellectual Property Management Co., Ltd. and manufactured by a medical device manufacturer in Shanghai.

As required by Shanghai municipal Party committee and government for “paving the last mile” of commercialization of research findings and promoting the application of the result, the Center for Certification & Evaluation, SHFDA, as the technical review agency in Shanghai, has joined the “customized addictive manufacturing knee orthosis” achievement transformation team composed of Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, SJTU Intellectual Property Management Co., Ltd. and Advanced Industrial Technology Research Institute of SJTU in October 2017. The Center is responsible for communicating the product standard, registration materials and production quality management system for 3D printing class II medical devices, and providing guidance to R&D institutions on early preparation for registration and application, including product performance research, biocompatibility evaluation, clinical evaluation, and production quality system construction and system document writing. The early intervention and guidance contributes to reduced preparation time for registration for research institution and early exposure of product risk to reviewers. After more than half a year of preparation, the product registration was formally applied on July 30, 2018 and approved on January 7, 2019.

The registration of the product mirrors the essence of the “registration applicant system” – relieving the pressure of R&D institution, optimizing business environment, releasing market vigor, encouraging technology innovation, accelerating industrialization of scientific and technological findings. It also indicates that the multi-sectoral linkage mechanism has been formed among Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University and Shanghai medical devices evaluation and approval institution and the industry-university-research-hospital collaboration channel has been established. As a successful case of SHFDA’s implementing reform initiatives and boosting biological medicine development, it has played a demonstration and leading role in enhancing industry-university-research-hospital collaboration innovation, and accelerating marketization new technologies and products.