卖方应为所有要供应的设备提交一份需要进行的工厂测试清单。
SELLER shall submit a list of Factory Tests to be conducted for all Equipment to be supplied.
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。
These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
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