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
 
Elsmar Forum Sponsor
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

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#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
Staff member
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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
Q JIS T 1115 Comparison (Japan Medical Device Standard) Japan Medical Device Regulations 0
shimonv Off-Label Use of a Medical Device in Japan Other Medical Device Regulations World-Wide 2
B Japan Medical Device Recall Requirements Japan Medical Device Regulations 4
E Japan - Medical Device Classification for Mass Spectrometry Japan Medical Device Regulations 2
P Sampling QC Requirements for Medical Electrical Device Export to Japan Japan Medical Device Regulations 1
N Need guidance on registration of medical device with MHLW (Japan) Japan Medical Device Regulations 1
A Japan - Medical Device Classification for Autoclave Tape Japan Medical Device Regulations 6
C Differences in Medical Device Approvals in various countries (US, EU, Japan) Other Medical Device Regulations World-Wide 1
F Class III Medical Device (Contact Lenses) Registration Timescale in Japan Japan Medical Device Regulations 4
R Japan Ophthalmic Optics Medical Device Registration Issues - Contact Lenses Japan Medical Device Regulations 6
N Japan Combination Medical Device Product Regulations and Requirements Japan Medical Device Regulations 2
B Japan (Ministry of Health, Labour and Welfare) Medical Device Labeling Requirements Japan Medical Device Regulations 2
S Medical Device or Cosmetic Device in Japan? Hand Held Wrinkle Reduction LED Light Japan Medical Device Regulations 3
J0anne GMDN (Global Medical Device Nomenclature) Australia, Japan, Turkey, Brazil Other Medical Device Regulations World-Wide 3
P Impact to Japan's medical device export after the nuclear power accident Other Medical Device and Orthopedic Related Topics 3
E Classification (Medical Device or Drug) of Blood Bag in Japan Japan Medical Device Regulations 6
M DEHP [Di(2-ethylhexyl) phthalate] containing medical device in JAPAN Japan Medical Device Regulations 1
T Japan Medical Device Product Registration Japan Medical Device Regulations 14
R Looking for Japan Medical Device Laws and Classifications in English Other ISO and International Standards and European Regulations 5
J JGMP and ISO 13485:2003 - The Japan GMP related to medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
L Bar coding - Medical device labelling - New Japan requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Refurbisher of medical devices in Japan Japan Medical Device Regulations 0
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
R Selling of Medical Power Supply in Australia/New Zealand and Japan Other Medical Device Regulations World-Wide 5
C Japan Regulations - Resistance of Medical Gloves to Permeation Japan Medical Device Regulations 1
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
J Requirements for Importing Research Use Only Medical Devices into Japan Japan Medical Device Regulations 1
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
A Aesthetic Treatment Medical Devices in Japan Japan Medical Device Regulations 2
A How does Japan PMDA classify Medical Devices - Classification Guidelines Japan Medical Device Regulations 6
D Reporting Medical Incidents in Japan ISO 13485:2016 - Medical Device Quality Management Systems 6
M Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement) Japan Medical Device Regulations 1
A Japan - Shonin question - Delay if Contract Manufacturer Moves? Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Japan Medical Devices Regulations Japan Medical Device Regulations 9
JoCam Electrical Testing for Japan, PSE or CB Scheme Other Medical Device Regulations World-Wide 0
V OEM / PLM Japan Japan Medical Device Regulations 1
M Brazil and Japan - Essential requirements Other Medical Device Regulations World-Wide 3
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 6
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
J Japan's Definition of Should and Shall Japan Medical Device Regulations 1
J MDSAP Regulatory Requirements other than in Japan, Brazil, Australia, Canada, US ISO 13485:2016 - Medical Device Quality Management Systems 3
J Japan AE (Adverse Event) Reporting Requirements Japan Medical Device Regulations 5
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
P Japan MHLW Ordinance No 94. (QMS structure Regulation) Japan Medical Device Regulations 1
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0

Similar threads

Top Bottom