Distribution of Medical Devices in US

R

regork

#11
We are the Initial Distributor (Company XXX, Inc-new premises here in the US). We have already registered with the FDA as an establishment. The manufacturer is Company XXX in the UK. We are a class I-per FDA.
I can help you out with a better answer if you tell me a little bit more about the scope of your initial importer (II) business. What activities does the II perform? Sales, Marketing, Installation, Service? The product is class 1, but what are the product's essential safety and effectiveness requirements, how is it used, and by whom? Use a risk based approach for the implementation of your QMS based on the activities you perform related to the regulations and your contractual responsibilities agreed upon with the MFG.

As an II, your registration must include the general device listing of all devices that you are the II for, even class 1 devices. This was a change made in 2012.

As an II, you need SOPs established to cover 820.198, 803.17 - how to receive, evaluate, and communicate when bad things happen involving your device.

It is important as a business for you to workout the roles and responsibilities between you and the manufacturer on customer complaint handling, adverse event handling, and device corrections and removals (21 CFR 806). You need to clarify how and when customer complaints (one that involve device complaints) are reported to the MFG, how they are trended, and who evaluates them to determine if they are reportable to the FDA under 803. When the medical devices changes to correct an FDA violation or a risk to health, is the II or MFG responsible for submitting a correction / recall report to the FDA and executing the activities. As an II, you are not required to have a written correction SOP, but I highly recommend you have it in place since these activities will be integrated with the external company (MFG) and you won't be doing it so frequent.
 
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