Class 1 medical devices selling

[babynelly2010]

Hello,

Does anyone know if I can sell non FDA approved medical device Class 1 on UK ebay internationally. The device is approved in EU and UK. This item is not available in US directly from retailer yet but there is a very high demand in America. I think I can make quite a bit selling from UK primarily to US market but I cant find anything saying that it will be OK to do.

Medical devices are generally assigned to one of three regulatory classes such as Class I, Class II and Class III based on the safety, effectiveness and level of control. If anyone wishes to see their example can follow the site www.allheart.com , www.ilexmedical.com/ etc. All devices are subjected to the limitations on exemptions set by the health regulatory boards. Manufacturers and distributors should register their establishments with these boards before selling product in the market.