premarketing

premarketing

1. The mechanism of the conventional medical endoscope in our country is introduced here, and its safe and effective performance is discussed in regard to requirements in premarketing evaluation.

介绍国内市场上常见的医用内窥镜的工作机理,结合目前的市场准入要求对这一类产品的安全性和有效性技术指标进行了探讨。

2. But if the product is a device, FDA has no authority to require premarketing proof of safety or effectiveness.

但是如果该产品为设备，FDA则没有权力要求其在上市前证明其产品安全有效性。

3. Premarket Factors

前市场因素

4. premarket difference

前市场差异

5. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97).

另外，请注意相关规定，“涉及入市宣告中的贴假商标行为”（联邦法规全书第21章807条97项）。

6. Premarket Approval

售前许可

7. Premarket Notification

售前通知(美国FDA产品申请方式)

8. If you are a small business, you may qualify for reduced fees, and you may also qualify for a waiver of the fee for your first Premarket Application.

如果你是一个小公司，你有资格可以申请减费，同时你也有资格申请豁免有关首次上市申请的费用。

9. premarket submission system

市场准入制

10. Premarket Admission

市场准入模式