Japan Medical Device Labeling Requirements

A

ArunGokul307

#1
#1
Dear all,

Do anyone know what are the languages Japan Regulatory body is going to accept in the instructions for use?

Can we add any additional languages apart from the specified languages?

Thanks in advance.

Best regards,

Arun
 
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A

ArunGokul307

#2
#2
Japanese in CE Mark Language Requirements

Dear all,

Can anyone explain why Japanese is one of the requirements in CE labelling requirements? How many language do we need to print on the IFU if we are to market the device in EU?

Thanks in advance.

Best Regards, Arun
 
Marc

Marc

Fully vaccinated are you?
Leader
#3
#3
Re: Japanese in CE Mark Language Requirements

NOTE: Merged 2 discussion threads since they are essentially asking the same thing.
 
Ronen E

Ronen E

Problem Solver
Moderator
#4
#4
Re: Japanese in CE Mark Language Requirements

ArunGokul307 said:
Dear all,

Can anyone explain why Japanese is one of the requirements in CE labelling requirements? How many language do we need to print on the IFU if we are to market the device in EU?

Thanks in advance.

Best Regards, Arun
Click to expand...
Hello ArunGakul and welcome to the Cove :bigwave:

I'm not aware of "Japanese being one of the requirements in CE labelling requirements". CE (EU) labelling requirements only relate to the languages formally in use within a member state of the EU (and I'm not aware of Japanese being one!).

With regards to "how many..." - there's no numeric figure for that. You need to analyse your situation - what EU member states the device is going to be distributed in/through, and what are the specific language requirements for each such state. To my knowledge there's no single location that lists those requirements. It's inconvenient, I know, but it seems that the only available course of action is doing the foot work, the hard way.

Cheers,
Ronen.
 
A

allengersgroup

#5
#5
I don't have much knowledge about Japanese Medical Device Labeling requirements. But as per me it should be in local language and in English as well. As I am new at this forum so I can't add link in my message. So you have to find it out from Google. Actually I found a link for you but forums guidelines not allow me to share any link.

You can also contact with the concerned authority regarding the same.

Always here to help !! Thanks
 
Q

QAengineer13

Quite Involved in Discussions
#6
#6
Hi Arun,

In relation to Labelling requirements in Japan , there is a mandatory "Electrical Appliance and Material Safety Law (DENAN)"

In the DENAN, ”Denki Yōhin” is classified into two categories - “Category A” and “Category B” 　

Category A product ： Need to obtain “Certificate of Conformity (CoC) by Registered Conformity Assessment Body (RCAB) = Registered by Japanese Government.

Category B product ： Not necessary to get CoC, but there is the obligation to conform to the Technical Requirements stipulated by the Ministerial Ordinance. Self- verification (confirmation) can be done by manufacturer.

There are many other products not being in scope of DENAN Law. And, even if subjecting to DENAN, there are also products being in scope of another regulation, e.g., therapeutic apparatus for households use, microwave oven, etc.

In simple word in order to claim compliance after necessary testing related activities , A PSE logo needs to be applied.
 
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