【medical_device_reporting】什么意思_英语medical_device_reporting的翻译_音标_读音_用法_例句_在线翻译

medical device reporting

医疗器械报告

标识 LABELING 医疗器械报告 MEDICAL DEVICE REPORTING 医疗器械；改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS ..

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短语

abstract: Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these institutions can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any adverse event caused by the device to MedWatch program for reporting significant adverse events or product problems with medical products.

以上来源于: WordNet

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.

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。

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These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.

这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。

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更多双语例句

Adverse event reporting has a critical role in the evaluation of the safety of a drug or medical device during its testing.

FORBES: The Data On Drugs' Side Effects Must Be Reliable

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