2015年7月,我国首个3D打印人体植入物——3D打印人工髋关节产品获得国家食品药品监督管理总局（China Food and Drug Administration,CFDA）注册批准。该产品也是国际上首个通过临床验证后获得注册的3D打印人工髋关节假体,标志着我国3D...2015年7月,我国首个3D打印人体植入物——3D打印人工髋关节产品获得国家食品药品监督管理总局（China Food and Drug Administration,CFDA）注册批准。该产品也是国际上首个通过临床验证后获得注册的3D打印人工髋关节假体,标志着我国3D打印植入物已迈进产品化阶段。本次获得CFDA注册的人工髋关节产品属于三类骨科植入物,是我国监管等级最高的医疗器械产品,是由北京大学第三医院骨科张克、刘忠军、蔡宏医生和国内最大的人工关节生产企业北京爱康宜诚医疗器材股份有限公司合作研制。展开更多
The Center for Drug Safety Evaluation from the Kunming Institute of Zoology （KIZ） acquired Good Laboratory Practice （GLP） Certification from the China Food and Drug Administration （CFDA） on June 30, 2015. This i...The Center for Drug Safety Evaluation from the Kunming Institute of Zoology （KIZ） acquired Good Laboratory Practice （GLP） Certification from the China Food and Drug Administration （CFDA） on June 30, 2015. This is the second pre-clinical safety evaluation organization to have obtained GLP Certification in the Yunnan Province and within the Chinese Academy of Sciences, and is also the first GLP center to have qualification for toxicokinetics testing in Yunnan.展开更多
文摘2015年7月,我国首个3D打印人体植入物——3D打印人工髋关节产品获得国家食品药品监督管理总局（China Food and Drug Administration,CFDA）注册批准。该产品也是国际上首个通过临床验证后获得注册的3D打印人工髋关节假体,标志着我国3D打印植入物已迈进产品化阶段。本次获得CFDA注册的人工髋关节产品属于三类骨科植入物,是我国监管等级最高的医疗器械产品,是由北京大学第三医院骨科张克、刘忠军、蔡宏医生和国内最大的人工关节生产企业北京爱康宜诚医疗器材股份有限公司合作研制。
文摘The Center for Drug Safety Evaluation from the Kunming Institute of Zoology （KIZ） acquired Good Laboratory Practice （GLP） Certification from the China Food and Drug Administration （CFDA） on June 30, 2015. This is the second pre-clinical safety evaluation organization to have obtained GLP Certification in the Yunnan Province and within the Chinese Academy of Sciences, and is also the first GLP center to have qualification for toxicokinetics testing in Yunnan.
