First, the overseas manufacturer (in this case, South Korea) needs to apply for the registration certificate of imported medical devices for this product in the US Food and Drug Administration in China. Ask Korean companies whether they have applied for this certificate in China. If not, it will probably entrust an agent in China to do it. The process is classified according to product risk, and the processing time is 5 to 25 months;
In addition, with the import registration certificate, you must also apply for a medical device business license. This process varies from region to region and takes about 1 to 3 months.
LZ provides so little information at present, and I can only help you answer so much.
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