Declaration of Conformity & CE marking for medical devices
Hi, I’m new to selling on Amazon. My product is imported from China and is a class I medical device. Amazon are asking for a Declaration of Conformity and CE marking to be allowed to sell it. I’ve looked into getting a Declaration of Conformity but it seems a bit unclear as to how to do this.
Does anyone have any advice on how to get a Declaration of Conformity? There are lots of products being sold in the medical supplies and equipment category so i’m thinking it must be achievable.
Thanks for any help!
Neil
12 replies
Seller_zWhFURNhcbesd
For the manufacturer who is putting the Medical Device Class I on the market within EU you need to …
… create technical file for each product
… issue a declaration of conformity for each product
… make a risk assessment of each product
… make sure that all the standards relevant to the product are met
That was a very short description, there is probably more but it has been a while since I worked with Class I and IIa products.
Please observe that manufacturer is not the same as the company that actually producing the product. It means also that if you sell it in your name/brand, you are the manufacturer.
Seller_EJIX7rqDNQJi2
Unfortunately, the majority of sellers whose offers you are seeing in the Medical Devices category obtained their approvals automatically, without having to provide any documents.
Amazon will rarely accept any documents supplied by Chinese manufacturers.
I would suggest you to wait until you establish a good selling history so that you get approved automatically.
Seller_r7SzViEUCuDPM
Make sure you’ve got good Public Liability Insurance too if you’re selling uncertified Chinese devices. 
Seller_zWhFURNhcbesd
If you buy this from another seller you cannot use their declaration of conformity for the items you have bought already from another.
You will will have to issue your own for this. I found this link pretty helpful: Conformace. OK, they want to sell but you can read about it, maybe it helps a little.
If the medical device is not sterile or is a measuring device, the process is easier and you do not have any notified body involved, nor do you need ISO certification. How the declaration should be worded, there are many templates on internet, like this one which is short and to the point.
Seller_iEWeGBJK5jyYk
Any device manufacturer is required to have ISO 13485 to produce medical devices to CE standard, the product (depending on what it is) should then be self certified for CE Mark and the manufacturer is then given a certificate, assuming it conforms to all the requirements. In short, if it isn’t CE Marked and they don’t have ISO, walk away…
