Domestic medical device products exported to the United States, Europe, Asia and other different regions, what are the requirements for product qualification

Medical devices of class 2 or above should be exported to the U.S. after FDA audit, and obtain K number according to the requirements of 510(k). EU countries need NB organization (i.e., Notified Body - Certification Body) to issue CE certificate after CE audit. Other countries generally have to apply for registration with the national regulatory authorities such as Australia, Thailand and so on. However, Asian countries such as Thailand recognize SFDA certificates.