How to distribute CE marked product for Japanese market?


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Japan requires Japanese label requirement but does not require CE mark.
So, usually, a medical device for EU market bears CE mark and a medical device for Japanese market bears Japanese label, even though the medical device for EU market is identical with the medical device for Japanese market other than label.

However, our company wants to make a single label for both EU market and Japanese market.

Notified body of our company said a medical device for Japanese market bearing CE mark must meet MDD and applicable EU legislation defining CE mark and indirectly said this means releasing the medical device for Japanese market bearing CE mark is not allowed before EC Declaration of Conformity is signed, even if the medical device is released only to Japanese market.
For some medical devices, it means that releasing Japanese market will be postponed, because EC Declaration of Conformity of the devices is later than Japanese certificate of them because of clinical evaluation for MDD, IEC tests for different voltage, confirming materials for RoHS directive and the like.

Can anyone tell me reason why Notified Body of our company can add restriction for releasing the medical device for Japanese market bearing CE mark, even though Notified Body is notified for MDD not Japanese legislation?


I would agree with the Notified Body. A device with a 'CE' mark, released before the DoC is in place is incorrectly labelled - where ever it may be.

The simple solution is to cover the CE mark with an extra small label - as long as it is not visible and the extra label is reasonably secure there is no problem.


I agree - Your NB isn't restricting sale from the Japanese market, it's saying that devices bearing the CE marking must comply with the MDD. This is regardless of where the device bearing the CE-marking is put on the market. If you want to release product in Japan before the CE-marking may be placed on the labelling, the product would need to not bear (or show) a CE-marking.


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Thank you for your idea.
It might be helpful, if our Notified Body and our designer agree with your idea.
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