应对这些投诉进行评估，并根据医疗器械报告制度(联邦法规21篇804或803部)要求决定它们是否需要向FDA报告。
These complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device reporting.
医疗器械的主要客户是医院，报告说，所以在一定程度上医院的成功将决定设备市场的成功。
The key customer of medical devices is hospitals, the report says, and so to some degree their success will determine the success of the device market.
聘请医生做顾问的制药公司及医疗器械生产商，将必须报告其支付给这些顾问的费用。
Pharmaceutical companies or medical equipment manufacturers who use doctors as consultants will have to report how much they pay them.
该报告指出，呼吸设备、导管、病人监护仪、以及牙科器械属于医疗器械中最大的类别。
The report indicated that respiratory equipment, catheters, patient monitoring, and dental equipment are the largest categories of medical devices.
在一份34页的详细报告里，FDA解释了其在确保美国患者使用安全有效医疗器械的方面的职责。
In a detailed report made of 34 pages, the FDA explains its role in ensuring American patients have access to safe and effective medical devices.
开展医疗器械不良事件监测和报告工作是十分重要的。
It is important to carry out the work of monitoring and reporting the adverse events of medical instruments.
针对辖区内医疗器械不良事件报告率低的现象，结合现行的监测管理模式，查找并分析原因。
Focusing on the phenomena that the reported adverse event of medical device is quite low, we use the method to analyze the cause on the base of actual monitoring management.
第十八条在中国境内进行临床试验的医疗器械，其临床试验资料中应当包括临床试验合同、临床试验方案、临床试验报告。
Article 18 in the territory of China for clinical trials of medical devices, the clinical test data shall include clinical trials contract and clinical trial scheme, clinical study reports.
医疗器械临床试验报告。
医疗器械不良事件报告覆盖范围窄，质量有待提高。
The scope that the reports covered is narrow and the quality needs to be raised.
目的通过对广东省2007年接收的可疑医疗器械不良事件报告表进行统计分析，为进一步开展监测工作提供参考。
Objective By analyzing the Medical Device Administration Events (MDAE) reports of Guangdong Province in 2007, to provide references for monitoring work.
结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。
Results Management of medical devices for safety and quality is to be achieved by means of reports of adverse events, recall and follow-up of medical devices.
结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。
Results Management of medical devices for safety and quality is to be achieved by means of reports of adverse events, recall and follow-up of medical devices.
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