Dec 29th, 2014, CFDA issued the Good Manufacturing Practice for Medical Device to strengthen the supervision and management of medical device manufacturing and standardize quality management. Whereafter, CFDA issued three Appendixes (Sterile Medical Devices, Implantable Medical Devices, In Vitro Diagnosis R...
2. “Quality Manager” means a person who is responsible for establishing,performing, and maintaining the quality control and quality management system of medical devices. 2.“质量经理”是指负责确立、执行、维系医疗器械质量控制与质量管理体系的人员。 3. A “Sterile Medical device” means a medical ...
As systems become more complex, procedures must be followed that organize and discipline the structure of development. Design controls must be enacted that increase the safety and effectiveness of medical devices. The FDA is in the process of changing these rules so processes must be defined and ...
2. Inspection of health based exposure limit (HBEL) assessments and use in quality risk management 基于健康暴露限值(HBEL)设定指南的问答 发布时间:2020/06 原文链接:https://picscheme.org/docview/1947 ISO 1.Medical devices —Post-market surveillance for manufacturers 医疗器械上市后监督指南 发布时间:...
7. Medical Devices; Quality System Regulation Amendments 医疗器械质量管理体系法规最终规章 发布时间:2024/02/02 8. Biologics License Applications and Master Files 生物制品许可申请和主文件 发布时间:2024/02/12 9. Use of Data Monitoring Committees in Clinical Trials ...
2. “Quality Manager” means a person who is responsible for establishing,performing, and maintaining the quality control and quality management system of medical devices. 2.“质量经理”是指负责确立、执行、维系医疗器械质量控制与质量管理体系的人员。 3. A “Sterile Medical device” means a medical ...
6.附件制造商(Manufactures of Accessories) 当成品器械制造商生产用于自制医疗器械的部件时,无论在同一器械内部还是在其他地方,这种部件的加工都被视为器械制造过程的一部分,因此必须遵守质量体系。 7.进口器械的一级经销商(Initial Distributors) 一级经销商第一个将器械进口到美国,并进一步销售该产品,GMP规定,该一...
2. Inspection of health based exposure limit (HBEL) assessments and use in quality risk management 基于健康暴露限值(HBEL)设定指南的问答 发布时间:2020/06 ISO 1. Medical devices — Post-market surveillance for manufacturers 医疗器械上市后监督指南 ...
Medical device QMS GMP system and audit
Remanufacturing of Medical Devices(Draft) 医疗器械再生产(草案) 草案ICH Q12:监管产品的实施注意事项 发布时间:2021/05/20 征求意见截止时间:2021/07/19 2. Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages ...