医疗器械申请CE认证FDA认证

CE认证跟FDA认证有什么区别?
CE认证是产品出口欧盟的认证，FDA认证是产品出口美国的认证，标准和检测项目都不同！
 

医疗器械CE认证符合性评估：

符合性评估是制造商表明其医疗设备符合CE标记条件的过程和程序，这取决于产品类别，欧盟有四类：

类1.第I

类2.第IIa

类3.第IIb

类4.第III类

医疗器械FDA认证有三个等级。

类1.第I类

类2.第II

类3.第III类

      在美国提交的同类产品历来对上市前通知（510（k））有不同的条件，而不是上市前批准（PMA），而欧盟产品批准提交仅基于类，每次提交必须满足完全相同的条件。因此，与具有zui新的综合510（k）或PMA应用的产品相比，缺乏技术文档的具有表面510（k）的产品将处于劣势。

What is the difference between CE certification and FDA certification?

CE certification is the certification of products exported to the European Union, and FDA certification is the certification of products exported to the United States. The standards and testing items are different!

Conformity evaluation of medical device CE certification:

Conformity assessment is the process and procedure for manufacturers to show that their medical devices comply with CE marking conditions, which depends on the product category. There are four categories in the EU:

Class 1. I

Class 2. IIa

Class 3. IIb

Class 4. Class III

There are three levels of FDA certification for medical devices.

Class 1. Class I

Class 2. II

Category 3. Category III

Similar products submitted in the United States have always had different conditions for the pre marketing notice (510 (k)), rather than the pre marketing approval (PMA), while the EU product approval submission is only based on the category, and each submission must meet the same conditions. Therefore, compared with products with the latest comprehensive 510 (k) or PMA application, products with surface 510 (k) without technical documents will be at a disadvantage.