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Overseas Registration

With the development and increasingly frequent communication of the medical device industry of China, domestic medical device manufacturers have increasingly strong demand for export.

Approval of the target country shall be obtained before export. Taking the U.S. as an example, FDA is an international authority for medical audit and empowered by the United States Congress to serve as the top law-enforcement authority for food and drug administration. FDA regulations on medical devices are divided into pre-market and post-market. With respect to pre-market, pre-market approval (PMA) and pre-market notification (PMN, i.e., 510 (k)), etc. are the core. 510 (k) is one of main channels for medical devices to be marketed in the U.S. Most Class II medical devices and some Class I and III medical devices are cleared through this channel.

Cover Countries/regions:

 The E.U. CE (MDD, IVDD, PPE and AIMDD);

The U.S. FDA (listing, 510K and PMA).