Скачать или смотреть What is the best approach to private labeling medical devices?

There is an overseas device manufacturer, and I want to private label their device. Can you help me?

Yes, of course. Medical Device Academy is a full-service quality and regulatory consulting firm. We help dozens of clients with private labeling. Before we start, we first need some basic information:
1. What's the device?
2. Does the manufacturer have 510(k) clearance?
3. Will you be importing? or just distributing?
4. Are you changing the packaging or labeling?
5. Do you have a quality system?
6. Who is the US Agent?
https://fda-us-agent.com/ - our website for US Agent services

You also need to determine which roles your company will be responsible for:
1. initial importer
2. complaint file establishment
3. repackager/relabeler

If you need help with registration and listing, here's an FDA link:
https://www.fda.gov/medical-devices/d...

Critical things to consider:
1. Who will have the UDI & GUDID account?
2. Who will handle complaints?
3. What will happen if there is a recall?
4. Does the supplier have liability insurance?