Tianjin Municipal Drug Administration's Innovative Mechanisms Drive High-Quality Development of Biopharmaceutical Industry

Source: China Quality News

Focus on Enterprises' "Urgent, Difficult, Worrisome, and Pressing" Issues; Efficiently Support with "Precision Drip Irrigation"

Tianjin Municipal Drug Administration Innovates Working Mechanisms to Support High-Quality Development of the Biomedical Industry

□ Wang Lin, Reporter of China Daily, Peng Xie

Intern Reporter Sun Huixian

Recently, the reporter learned from the Tianjin Municipal Drug Administration that Just Medical's "Biological Knee Joint Prosthesis System" has been approved by the National Medical Products Administration as a Class III medical device.Innovative HealthcareInstrument, becoming the 9th approved product in Tianjin.

By 2025, Tianjin has approved the market entry of four Class III medical device products, marking an 80% year-on-year increase, with the total number firmly ranking among the top in China. These figures vividly illustrate Tianjin's activation of innovation momentum in high-end medical devices through comprehensive policy support, precision-targeted service mechanisms, specialized innovation platforms, and integrated ecosystem construction.

In the medical device industrial park of Dongli Economic Development Zone, Tianjin, more than 10 biopharmaceutical projects are under development. Eight innovative transformative medical devices are in the research stage, five of which have entered clinical trials. From encouraging original breakthroughs at the research end to establishing green channels for registration, and further ensuring supporting elements for industrialization, the "full-chain support policy system for biopharmaceutical innovation and development" constructed by Tianjin in recent years continues to play a significant role.

In 2025, the Tianjin Municipal Medical Products Administration, focusing on enterprises' "urgent, difficult, worrying, and challenging" issues, has precisely formulated 27 special reform measures. Concentrating on the entire chain of R&D, registration, and production, these measures employ innovative mechanisms such as early intervention guidance, collaborative R&D and review processes, and opening green channels. These actions directly address critical bottlenecks like long evaluation cycles for innovative medical devices and difficulties in their transformation and implementation, providing full-process acceleration for innovative products. This forms a strong driving force supporting the high-quality development of Tianjin's biopharmaceutical industry.

It is reported that the "Biological Knee Joint Prosthesis System" is suitable for non-cemented prostheses and is used for primary total knee replacement. The system has overcome key technical challenges such as biocompatibility and long-term stability, breaking the partial technological monopoly of foreign high-end knee joint prostheses. During this process, the National Medical Products Administration organized expert discussions on technical difficulties multiple times. The Tianjin Medical Products Administration provided proactive services, relying on the mechanism of the "Key Medical Device Product Service List" among the 27 policies to coordinate testing resources for prioritized product inspection and GMP (Good Manufacturing Practice) compliance checks. At the same time, it collaborated with the high-end medical device innovation transformation industrialization public platform to provide full-process support for the establishment of a quality management system and registration application, promoting its recognition as Tianjin's 9th Class III innovative medical device.

As a leader in the research and development of non-invasive brain-computer interface technology in China, the Haihe Laboratory of Brain-Computer Interaction and Human-Machine Symbiosis urgently requires professional guidance for its innovative product commercialization. The Tianjin Drug Administration quickly responded by forming a specialized service team consisting of experts in drug registration, medical device evaluation, and testing. A pioneering "technology-policy-evaluation" integrated mechanism was established to address core processes such as registration applications, testing, and system verification. Tailored "one product, one strategy" solutions were developed for the laboratory's series of transformation products, providing comprehensive technical guidance throughout the entire process—from analyzing technical key points, pre-reviewing application materials, to tracking evaluation progress.

"The experts from the Drug Administration not only helped us organize the application process chart but also addressed the clinical evaluation standards for the EEG acquisition system and the exoskeleton."Robot"The 'one-on-one' guidance on key steps such as biocompatibility testing has helped us avoid many detours," said Ni Guangjian, the executive deputy director of the Brain-Computer Interaction and Human-Machine Symbiosis Haihe Laboratory. Driven by this mechanism, two products from the laboratory, including the brain-computer intelligent artificial neural information system, have been approved for marketing; products like the EEG acquisition and event-related potential system have entered the "fast track" for review and approval, forming a typical demonstration of full-chain acceleration in "research-development - transformation - market entry."

Walking into the R&D center of Tianjin Yingtai Li Ankang Medical Technology Co., Ltd., the陡脉冲治疗设备 (steep pulse treatment device) in the laboratory is undergoing final performance debugging. Recording data, optimizing parameters... multiple cutting-edge innovative medical device products are accelerating from blueprint to physical form. "From the laboratory to the production line, we have received full-process support for testing, clinical trials, and registration applications," said Xue Zhixiao, the company's R&D director.

Tang Nan, a relevant official from the Tianjin Medical Products Administration, stated that by 2030, the scale of Tianjin's high-end medical device industry is expected to grow significantly compared to the present, better meeting the public's demand for high-quality healthcare.