国家药品医疗器械标准 the national standards for drugs and medical devices
药品医疗器械飞行检查管理办法 the Provisions for the Flight Check of Pharmaceutical Products and Medical Devices
药品和医疗器械管理局 PMDA
另一种观点则坚称应该对这些测试做风险级别上的监管，这些风险级别需要被标注在产品之上，为消费者所知(就像药品器械被评估分级那样)。
But others assert that tests should be regulated based on the level of risk they pose to the consumer (as medical devices are ranked and evaluated).
它证明了该部门不再处在对做出药品和器械安全决定所需要的信息的垄断地位。
It demonstrated that the agency no longer had a monopoly on the information needed to make drug and device safety decisions.
美国人很愿意就医疗器械的标准达成一个协议，然后推敲出不同的合同，用以涵盖-- 比如说-- 电子产品和药品的生产。
The Americans would happily reach one accord on standards for medical devices and them hammer out different pacts covering, say, electronic goods and drug manufacturing.
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