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Hello, I have a few questions. The first part is are there any potential PMS activities for products that may not be medical devices per MDR? If we successfully convince our NB that certain items are not medical devices (such as power supply, power cords, printer cable, travel case), I presume ...

You should consider Nihon Koden. My former company had a good experience with them. ------------------------------ George Tiller Los Angeles CA United States ------------------------------

Hello, No you don't need to provide that information to list the device on WAND. For the manufacturer portion of the WAND draft notification, you just need to list your legal manufacturer. My former company's legal manufacturer is based in Switzerland, however, all of the physical manufacturing ...

Hello, Yes, you need a local sponsor ((New Zealand) NZ legal entity) as the representative. Yes, the sponsor needs to register themselves in WAND (see WAND User Guide Version 3.1 Step 2, file attached). For now the MEDSAFE requirements are lax; however, NZ is planning on transitioning to a more ...