Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen

#1
Hi,

I run a handful of online stores and have recently been exploring importing a branded Electric acupuncture pen into Germany. However usually I sell clothing and I have been shocked at the amount of regulations it looks like I will have to comply with. There is a very relevant thread here, but there wasn't any conclusions posted. Where should I get started? My Chinese supplier has CE certification, and has proven to me he has sold a couple thousand of these in Europe. I can find similar ones all over European stores, however I can't find a single one that has any certification beyond CE, whereas it looks like they need a lot more than that.
 

Jaydub

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#2
CE is what you need. What you need for CE is dependent on your product. You say the product is CE marked, but under what directive(s)? If it is a Medical device you would need to comply with the Medical Device Directive or the MDR. You will need a representative in the EU. You may or may not need a Notified Body, depending on your device classification.
 

moounir

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#4
Apparently, in your case, there are a lot of things you need to be careful.

- First, as dgrainger said, this is a Medical Device which needs a Notified Body to certify the product. If your Chinese Manufacturer has a CE mark, then you need to get it to understand which Notified Body approved it. And check on the NANDO database if this Notified Body is accredited for Medical Device products.

- Second, do you want to sell this product under your own name (Own Brand Labeling) or just act as a distributor? In the first case, I really not advise you to do it If you are not knowledgeable on Medical Device. In the case you want to be a distributor, then the Chinese Manufacturer needs an Authorized Representative in Europe as Jaydud mentioned, and an Importer in Europe. I would also advise you to not become an authorized representative or importer for this company if you don´t know them.

- Third, you will be the company marketing this product. So if you claim something that is not proved, it can be a problem for you. So check first if there are clinical data for what they claim.

So conclusion, you are entering a difficult area. You can learn how Medical Devices are regulated and find your way to distribute this kind of product. But if your business is not focused on Medical Devices, hire a consultant to help you if the business is important. Don´t jump on this kind of business without a minimum of security.

I hope this helps.
 

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