Bin Liu,
Director of the Division IV, Center for Medical Device Evaluation, National Medical Products Administration
liubin@cmde.org.cn
Biography:
刘斌，国家药监局医疗器械技术审评中心审评四部部长，研究员，十三五国家重点研发计划《新型医用金属材料及植入器械产品标准及其审评科学基础研究》项目首席科学家。中国生物材料学会骨修复与器械分会副主任委员，国家科技十三五重大专项总体专家组成员，国家科技专家库、国家科技奖励专家库评审专家，骨科外科植入物标准化技术委员会主任，口腔标准化技术委员会主任。作为骨干，参与定制医疗器械法规制定，并主导了相应技术规范研究工作，建立了个性化定制医疗器械技术审评创新模式和审评规范。作为主要起草人主导了起草了国家标准《外科植入物用多孔钽X射线无损检测方法》、《外科植入物用多孔钽材料》等数十项项国家和行业标准的制修订定工作。
Liu bin is the director of the Division IV, Center for Medical Device Evaluation, National Medical Products Administration. He is also a researcher and the chief scientist of the project "Scientific research of product standard and evaluation of new metal medical materials and implant device ", the National Key Research and Development Program of China’s 13th Five-Year Plan. Deputy director of the bone repair and equipment branch committee of China biomaterials society. Member of the overall expert group of national science and technology 13th Five-year major projects. Evaluation expert of national science and technology expert database and national science and technology award expert database. Director of technical committee on standardization of orthopedic and dental surgical implants. He has participated in the formulation of custom medical device regulation, drafted corresponding guidance and set up innovation model and review of standards for personalized medical device. As the main drafter, he led the drafting of dozens of national and industrial standards, such as "methods for X-ray nondestructive testing of porous tantalum for surgical implants" and "porous tantalum materials for surgical implants".
Topic title：医疗器械监管科学研究-新材料研究整体部署与实施
Abstract：本次报告刘斌将围绕新材料监管科学研究展开介绍。通过建立创新和完整的医疗器械评价方法，保证医疗器械产品的安全性、有效性和可及性，保障公众用械安全，推动研发转化，促进医疗器械行业发展。
In this report, Liu bin will introduce the scientific research on the regulation of new materials. Through the establishment of an innovative and complete evaluation method for medical devices, the safety, effectiveness and accessibility of medical device products are guaranteed, the safety of public devices is guaranteed, the transformation of research and development is promoted, and the development of the medical devi