Medical Device Labeling - Understanding the Regulations 標籤完整性 製造商必須確保其醫療器材上的標籤在整個生產過程(包括分類、處理和分發)中完整且牢固地貼上。如果在運輸或儲存過程中容易脫落,符合文字要求的標籤就會失去其價值,可能導致混亂、不正確的擱置或設備的錯誤識別。因此,確定標籤耐磨損對於維持 FDA 合規性...
FDA Medical Device Regulations vs. ISO 14155Requirements per 21 CFRrelating to the investigator's participation inan investigation: Correspondence Device disposition Subject case history, including informed consent, relevant observations such as adverse device effects, and exposure to the ...
–800-861: cross-cutting device requirements(横切装置要求) • Example: 812 - Investigational Device Exemption(研究器械豁免) –862-1050: device-specific requirements(特定设备要求) • Example: 876 - Gastroenterology and Urology Devices(肠胃科和泌尿科器械) • 21 CFR: Parts 1-99 –general medic...
按照FDA eMDR最终规则(Federal Register : Medical Device Reporting: Electronic Submission Requirements),要求器械制造商和进口商向FDA提交单个医疗器械不良事件的强制性报告,又名医疗器械报告(MDR),以电子版的形式交给FDA,且该电子版允许FDA处理、审查和存档,继续以FDA FORM 3500A表格形式提交报告。 MDR法规(21 CFR ...
1.食品接触材料的FDA检测 2.激光产品FDA注册 3.医疗器械FDA注册 4.化妆品和日用品FDA检测报告 5.食品...
1. Know Your Device’s Classification Medical devices fall into three classes: Class I Class II Class III You should know your device’s classification before the development process begins. The class of device will correlate to how you’ll need to manage requirements and testing. The class of...
specifiedrequirementshavebeenfulfilled. Sec.820.5质量体系/ Qualitysystem. 制造商应建立并实施适应特定的医疗器械设计或制造,并符合本部分要求的质量体系。 Eachmanufacturershallestablishandmaintainaqualitysystemthatisappropriateforthe specificmedicaldevice(s)designedormanufactured,andthatmeetstherequirementsofthis ...
Medical device establishments with devices subject to FDA UDI requirements must obtain a Data Universal Numbering System (DUNS) number. 唯一设备标识符(UDI)和全局唯一设备标识符数据库(GUDID)UDI合规性日期 GUDID报告证书 分布在美国的大多数医疗器械需要将数字或字母数字代码作为唯一的设备标识符(UDI)。 FDA还...
In addition, any person who reprocesses a single use device for reuse becomes the manufacturer of the device and is subject to all the requirements applicable to the original manufacturer, including the requirements of the MDR regulation, FDA says. ...
□ 器械建议的标识要求Labeling requirements from Device Advice ■ FDA认可共识标准: 标准编号 标准名称(中英文对照) AAMI/ANSI HE75 Human factors engineering - Design of medical devices 人因工程-医疗器械设计 ANSI/AAMI/IEC 62366-1:2015 (R2021)+AMD1:2020 ...