Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff (上市前申请评估的质量体系信息;行业指南和FDA工作人员指导) 设计控制 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...
Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff (上市前申请评估的质量体系信息;行业指南和FDA工作人员指导) 设计控制 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...
1. Request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities WHO药品预认证部门要求生产商执行亚硝胺杂质风险评估 发布时间:2020/04/02 2. Good chromatography practices 良好的色谱规范 发布时间:2020/04/21 3. Good manufacturing practices: wate...
该标签规章要求器械标签的制造商名字不是初始制造商(original manufacturer),并且应选用那些揭示其与器械的生产关系的合适的措词,譬如,由某某公司再加工。 定制式器械制造商(Custom Device Manufacturers) 食品、药品和化妆品法的第520(b)节和研究用器械豁免(IDE)规范联邦规章典集第21篇812.3(b)篇都对定制式器械进行...
1. Medical devices — Post-market surveillance for manufacturers 医疗器械上市后监督指南 发布时间:2020/07/20 IMDRF 1. IMDRF/AE WG/N43 FINAL:2020 Updated Annexes (Edition 4.1) 更新医疗器械不良反应报告分类的术语 发布时间:2020/07/27
Section 820.100(a)(l) of the GMP regulation requires that manufacturers of medical devices establish specifications for all devices, including the components, packaging, and labeling. Section 820.100@) requires that where deviations from device specifications could occur as a result of the manufacturing...
290 -- 1:27:59 App Process Validation for Medical Device Manufacturers 384 -- 1:58:48 App Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses 71 -- 46:02 App Non Viral Delivery of self amplifying mRNA Vaccines March 31 Webinar 79 -- 1:33:32 App Pharmaceutical Quality Sy...
2. Food manufacturers have implemented GMP standards to prevent any contamination in their production lines. 食品制造商已实施GMP标准,以防止生产线上的任何污染。 3. The medical device industry must comply with GMP regulations to ensure the safety of the products used by patients. 医疗器械行业必须遵守...
medical devices, as well as the requirements for designationprocedure and management method of a Medical device QualityManagement Review Agency, as provided in Paragraph 7 of Article 10,Paragraph 1 of Article 13, Paragraph 6 of Article 15, and Article 28 ofthe 「Medical device Act」, and Item...
(2) 5 years for the products with the medical devices, etc. other than the specially designated maintenance control required medical devices (one year plus the shelf life for the products of which the shelf life plus one year exceeds 5 years). ...