FDA医疗器械质量体系手册

FDA医疗器械质量体系手册When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation.当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。

Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation.附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。

然而，FDA认为它们是成品器械因为它们可以使用于或作用于并且销售来为健康相关的目的；并且QS法规要应用When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation.当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。

Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation.附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。

然而，因为它们可以使用于或作用于并且销售来为健康相关的目的，FDA认为它们是成品器械；并且QS法规要应于其生产。

同样的，装置或零件包括软件是作为成品医疗器械的附加部分销售的，以增加或补充其性能，也作为附件器械对待。

既然医疗器械的附件是作为成品来对待，因而受QS法规制约。

A remanufacturer is any person who processes, conditions, renovates, repackages restores or does any other act to a finished device which has been previously distributed to significantly change the finished device's performance or safety specifications or intended use from that established by the original finished device manufacturer. Remanufacturers are considered manufacturers. As such, these manufacturers are subject to inspection by FDA and shall meet the applicable requirements of the medical device QS regulation. These manufacturers shall establish and implement quality systems to assure the safety and effectiveness of the devices that are distributed. Such activities include drafting of master records, rebuilding per the master records, inspection and testing, calibration of measurement equipment, control of components, updating of labeling, processing of complaints, and any other GMP requirement applicable to the activities being performed.再加工者是对成品器械进行加工、翻新、整修、重新包装修复品或任何其他行为来明显改变该经过销售的由原来的成品制造商所设定的成品器械的性能、安全指标或使用目的的人。

再加工者也被视为制造商。

同样地，这些制造商要接受ＦＤＡ的检查，并满足医疗器械质量体系规章可适用的要求。

这些制造商也应建立和实施质量体系，确保其销售的器械的安全和有效。

这样的行动包括器械主记录的起草、对照器械主记录重制造、检查和测试、测量仪器的校准、部件的控制、标签的更新、投诉的处理和其他在其活动中可适用的GMP 要求。

Remanufacturers are also required to comply with the labeling requirements of 21 CFR 801.1(c). This labeling regulation requires that where the person or manufacturer named on the label of the device is not the original manufacturer, the name shall be qualified by an appropriate phrase which reveals the connection that person has with the device, e.g., remanufactured by XYZ Company.再加工者同时也被要求遵守联邦法规第21 篇第801.1（c）节中对标签所作的规定。

该标签规章要求器械标签的制造商名字不是初始制造商，并且名称应选用那些揭示其与器械的关系的合适的措词，譬如，由某某公司再加工。

Custom Device Manufacturers定制器械制造商Section 520(b) of the FD&C Act and the IDE regulation (21 CFR Part 812) define a custom device. Custom devices are exempt from certain statutory requirements. For example, manufacturers of custom devices are not required to comply with premarket approval requirements (Section 515) and are exempt from premarket notification requirements [Section 510(k)]. Custom devices are NOT exempt from the GMP requirements. Current FDA policy, however, is to not inspect manufacturers of custom devices. Manufacturers of custom devices should comply with the GMP requirements while considering the flexibility allowed.食品、药品和化妆品法的第520（b）节和联邦法规第21篇812.3（ｂ）篇研究用器械豁免（IDE）法规都对定制式器械进行了定义。