(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.
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Product means components, manufacturing materials, in - process devices, finished devices, and returned devices.
产品是指部件,制造材料,在加工设备,成品设备,并返回设备。
The QS regulation applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect.
除非获得有效的豁免批准,QS法规适用于以销售为目的的人用医疗器械制成品。
Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA.
成品器械的合同式制造商应遵从质量体系中可适用的要求,并向FDA登记其产品。
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