Importing Medical Devices: A Step-by-Step Guide | Scilife

You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regulatory clearance/approval in the US market. Without being able to import your medical devices, all the hard work that came before becomes irrelevant. In this post, we will review the regulatory framework around importing medical devices into the US, the..