1, FDA is the U.S. medical device 510K registration certificate; and the medical device registration certificate is usually the domestic medical device registration certificate of the statement;
2, through the FDA certification, the enterprise must have the QSR820 system certification, and then the product can apply for a 510K registration certificate;
And the domestic medical device registration certificate, you only need to YY0287 audit report, you can,
3, FDA registration certificate is expensive, long cycle, there is an annual inspection fee, about 1200 U.S. dollars;