January 25, 2024 EU MDR Virtual Importers While I can see potential benefits of voluntarily creating an importer (along with the additional regulatory burden) to add a layer of compliance checks and balances, I strongly advise against the basis being an assertion that end users need regulation because they have, as one person […]
<h1 class="entry-title">Category: Import</h1>
UK and EU End Users Are Not Importers
January 25, 2024 UK and EU End Users Are Not Importers Generally speaking, end users are not considered to be importers. This is the same for the UK and the MDD/MDR alike. For example, the European Commission’s Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR, specifically […]
Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary
February 20, 2023 Transferring Foreign 510(k) “Ownership” to Domestic Subsidiary In a nutshell, if a foreign sponsor/owner of a U.S. FDA 510(k) clearance wants to transfer/relinquish ownership and control over to its U.S. subsidiary (or any other party), then such a business/regulatory model can have regulatory merit and, if properly configured/managed, can generally work […]