收到已由其他制造商包装和标识前制造的器械,并把成批收到未包装的其他器械和它们组装成套。 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...
关键词医疗器械GMPQS质量体系一“良好制造规范(GMP)/质量体系规章”网Manu—1前言美国FDA现行的良好制造规范(GoodfacturingPractice页有一指向“医疗器械质量体系手册.小型企业遵从指南(第一版)”(MedicalitySystemsManual:ADevices,GMP)在质量体系Qual~Com—(Qualitysystem,QS)规章中提出,发布在andSmallEntity联邦食品、...
Design Control Guidance For Medical Device Manufacturers (医疗器械生产设计控制指南) 人为因素 Human Factors and Medical Devices (人为因素与医疗器械) 其它相关信息 Workshops & Conferences (Medical Devices) (会议与研讨会(医疗器械)) CDRH Learn What is the relationship between FDA’s Quality System Regulati...
Vina P, Rubio S, Sandle T. 消毒剂的选择和验证。In Saghee MR, Sandle T, Tidswell EC (eds) Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. 新德里:Business Horizons;2011:219-36。↩︎ Kramer A et al. 柳叶刀,2002;359:1489-90。↩︎...
3. Reflectionpaper on Statistical methodology for the comparative assessment of quality attributes in drug development 药品研发中关于质量属性可比性评估的统计方法学的思考性文件 发布时间:2021/07/27 FDA 1. ICH Q12: Implementation Considerations for FDA-Regulated Products Remanufacturing of Medical Devices(...
附属器械(accessory device)在联邦规章典集第21篇第807部和《器械制造商的企业注册与器械列表》(Establishment Registration and Device Listing for Manufacturers of Devices)中已讨论。这些器械,如血液透析试管或X射线诊断部件,以健康相关的目的,单独地包装、标识并销售给医院、医师等,经常被错误地当作部件。然而,FDA把...
10. FDA | Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program 《医疗器械的生物相容性测试 - 合格评定认可计划 (ASCA) 计划的标准特定信息》 发布时间:2024/09/23 ...
医疗器械韩国KGMP(Korea Good Manufacturing Practice for Medical Devices)认证的申请通常需要通过韩国食品药品安全厅(Ministry of Food and Drug Safety,MFDS)进行。以下是申请流程的一般指南:申请流程:了解要求和标准:在开始申请之前,仔细了解KGMP认证的要求和标准,以确保您的医疗器械生产和质量管理体系符合标准...
It is also intended to be used in conjunction with the interpretations published in the Device Good Manufacturing Practices Manual, Medical Device GMP Guidance for FDA Investigators Manual, and the GMP Workshop Manual for Sterile Medical Devices. The notice of availability of the draft guideline ...
12. FDA | Chemical Analysis for Biocompatibility Assessment of Medical Devices 《用于医疗器械生物相容性评估的化学分析》 发布时间:2024/09/19 该指导文件草案提供了 FDA 关于分析化学测试的建议,以评估医疗器械的生物相容性。 13. FDA | Conducting Clinical Trials With Decentralized Elements ...