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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Medical implant devices are prepared from a polymeric material and a release agent, where the device is a molded, reservoir implant, and the release agent has a molecular weight (MW) of at least 1000.

医疗植入装置是由聚合材料和脱模剂制备的，其中所述装置是模制成型的贮液植入物，并且所述脱模剂具有至少1000的分子量(MW)。

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