CE Marking a CE marked Class I Medical Device - To aid approval/registration in China

J

jampot

#1
To aid approval/registration in China of our Class III device, it has been suggested that the easiest way to do this is to first obtain a CE mark for a Class I device.

As a consequence I am considering asking an instrument company that I know to provide one of their CE marked instruments (and access to their technical file), mark with our company name and submit this Class I device for EC Design Examination.

Would anyone on the Cove be able to advise what documentation is required...on the basis I can refer the the original manufacturers CE mark approval.

Thoughts/advice appreciated

Thank you.
 
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A

Alexisss

#2
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

To aid approval/registration in China of our Class III device, it has been suggested that the easiest way to do this is to first obtain a CE mark for a Class I device.

As a consequence I am considering asking an instrument company that I know to provide one of their CE marked instruments (and access to their technical file), mark with our company name and submit this Class I device for EC Design Examination.

Would anyone on the Cove be able to advise what documentation is required...on the basis I can refer the the original manufacturers CE mark approval.

Thoughts/advice appreciated

Thank you.
Hello,

Class III with Class I certification procedures are similar by a small percentage.

For Class III certification you need a notified body (Europe-based at http://ec.europa.eu/enterprise/newa...99999&prc_id=99999&ann_id=99999&prc_anx=99999 - you may ask them for their Chinese counterpart if existent, or search for a local list of NBs).

For Class I you self-certify the compliance with the essential requirements of the Medical Device Directive 93/42. This means you do not involve a NB at all (except if your device has measuring function or if it is sterile).

Check the classification rules (http://www.meddev.info/ - although there have been some amendments to these lists and they are not totally up to date) and see whether you can only classify your product as Class I.

Make note that you need to have the correct labeling on the product/packaging, therefore if you have a Class III special wound dressing but want to market it as Class I, then you need to clearly indicate on your packaging and/or instructions that your special wound care product should only be issued as a mechanical barrier (... as a tissue!).

Keep in mind that in the latter case you are risking to be accused of fraud and/or unfair competition (because a competitive Class III product may look alike, and has incurred the cost of certification, which you avoided). I have seen this happening! Also, one could say that marketing a Class III product as Class I (to avoid the NB) jeopardizes patients' safety, and if something goes wrong with a patient you never know how you will be affected if you get what I mean.

Therefore may be it is a good idea to consult a NB who will tell you the whole proper procedure, and do it right from the beginning.

Good morning!
 

Marcelo

Inactive Registered Visitor
#3
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

Just to make it clear, it´s againt the law (the directive - Article 18
Wrongly affixed CE marking) to apply CE Mark in this case.

I´m also moving this thread to the CE Marking forum.
 
J

jampot

#4
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

Many thanks for this advice - grateful.

One quick point, regarding China. I'm not trying to register a Class III device as a Class I device, rather to make a future submission of our Class III device, I've been advised that it would be easier from a registration perspective to obtain approval for a Class I product (in this case an instrument). Hope this clears up this issue. I'm certainly not suggesting that I'd be trying to deceive the Chinese FDA here.
 

Marcelo

Inactive Registered Visitor
#5
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

Ah, ok, i misinterpreted what you said before. Thanks for the clarification.
 
J

jampot

#6
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

Having done a little more research on this subject, I've realised that this approach is know as 'Own Brand Labelling' CE marking.

Does anyone have any experience of this approach with a Class I device?

Many thanks
 
M

MikeEmergo - 2010

#7
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

China. It's a great market, and they WANT to purchase high quality medical devices.

Requirement to sell into China is first clearance in your "home-country". So if you are from the US, you need FDA clearance. If you are in Europe, you need to CE mark your device first (and all that goes with it).

I can tell you they will require that you have your home-country clearance/approvals first.


The State Food and Drug Administration (SFDA) of China requires that all medical device, IVD and pharmaceutical companies with no location in the People's Republic of China appoint a registered Legal Agent and After Sales Service Agent (in-country regulatory representative). Appointed Legal Agents and After Sales Agents must be residents of China OR maintain a place of business in China. You will need a Legal Agent and After Sales Agent in China .


Own Brand Labeling
Since you are CE marking the device, and you are on the labeling, with the OBL, then you are technically considered now, the manufacturer.
 
Last edited by a moderator:
A

Alexisss

#8
Re: CE Marking a CE marked Class I Medical Device - To aid approval/registration in C

Wasnt the question on CE marking for selling in Europe? or "certification/licensing in order to sell in China"?
 
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