On the morning of Nov. 16, the four-people steering group led by Wang Zhexiong, Head of the Department of Medical Device Supervision of National Medical Products Administration, paid a visit to Zhenghai Bio-tech accompanied by Ren Shaoyan, Director of Shandong Medical Products Administration, and checked the execution of the production quality management practices.
Mr. Sha Shuzhuang, General Manager of Zhenghai Bio-tech, and Ms. Jiang Shaoxia, a representative of the management, reported the overall situation of the company, the construction of new plants and the execution of regulations on the management of production quality respectively. At the same time, they put forward suggestions on laws and regulations, registration and inspection, inspection entrusted by third parties, etc., looking forward that the developed products will be put on the market as soon as possible to benefit patients.
After listening carefully to the report, Wang Zhexiong praised the development of Zhenghai Bio-tech in the field of regenerative medicine, hoping that Zhenghai Bio-tech will further study laws and regulations, enhance the life cycle management of medical devices and monitoring of adverse events, and constantly minimize the product quality risk; increase the investment in the R&D, design and development of products, and carry out scientific and complete clinical trials based on the clinical needs to ensure safe and effective products on the market. We look forward that Zhenghai Bio-tech will develop more innovative products to benefit society and patients.
Director Li Wei, and Deputy Director Du Pin of Yantai Food and Drug Administration also accompanied the delegation.