User Manual and Label Language Requirements

Hi to Everyone

Thanking as always for your guidance. I would like to place the question of Language for Labeling:

Well as manufacturer we do not have some resources to make all the translations and our subsidaries would like to take it up themselves, esp in EU. But is it a requirement that the Translation Services must be Certified to something(like a norm). E.g.When i asked our language services they told me, that they are certified for ISO 9001:2000. Or is it just enough that they are competent.

Eager to see the thread grow.

Thank you.

Re: User Manual Language Requirements

I'm not aware of any requirement, except what the customer would dictate in a contract.

Based on some of the users manuals and assembly instructions I have reviewed, even if there was such a requirement it would not necessarily guarantee quality-- just like ISO 900X does not guarantee quality.

Well, the entire issue revolves around costs. That the certified Services charge you more. But the end of the day, the customer should get a Instruction for use in the official language. So i dont really see any requirement for a certified service.

But some of our people would like to see a certified service do it.

Indeed in some countries the translation cost masks the profit you earn for 1 or 2 devices you sell. Is there any other solution, how does the other companies go about for such translation requirements?

Just some quick thoughts:

Letting your subsidiary create product labeling will require an added measure of vigilance on your part. Personally, I discourage taking this course. For instance, how will you confirm that the language translations are correct? How will you control content? In my estimation, you’ll burn more time, money and energy trying to do your part in ensuring that you aren't placing misbranded product into the market place. I understand that money is a concern here, but FDA and other international health ministries don’t care if your business makes on cent on the product you sell. They are only concerned that the public at large is not placed in harms way because of your product (including product labeling). I generally like to work from an established business case when considering where we plan to register and market product. One of the key issues that can stop a deal is the feasibility of getting a translation in the national language you need. Contact the Competent Authorities and see if they will grant your organization an exemption. You may even want to have the customer of that nation write a letter lobbying for a device in a language that you do offer. Some states do accept alternate languages, so check that out nation by nation. Other countries are strict on labeling, so the option to sell will not exist.

Give it some serious thought.



Kind regards,

Kevin

Timing is everything. At today's weekly Quality System meeting, we discussed translations for a product we're submitting for CE approvals. Your comments helped answer some of the questions that were raised. Thanks for your contributions.

First, Thanks to the participants and their valuable comments. The other opportunity where it seems nebulous for us, is the translation of software or GUI data, what is the solution if certain parts cant be translated. How should we address it?

Krishna007,

As you are probably aware, certain languages translate easier than others. Some languages do not have exact translations, so substitutions will have to be used. The aim here is to ensure that nothing is lost from an intended use perspective. Your risk management activity should also capture the issue and mitigate it as appropriate with rationale. What is the nature of the problem that you are running into?

Regards,

Kevin

If your shipping your product or no matter any thing outside your Country...you should provide the Language Translation statement in the "User Manual" and you should have the QSP for this process!

If more than 10 customer's request your company to provide in the local language, your entitled to provide the same to the user.

You can use the below statement in the "User Manual"

Declaration of Language Translation
"Product Name" comes to you as a package, complete with Labels, User Manual and related documents, all of which are in English. The product targets "which customer" who are proficient in the language and can read the instruction understand the product better. All these instructions guides will be supplied in the local language on request by the customers.

If you need copy of the QSP, let me know....I can get you one soon!

Re: User Manual Language Requirements

Jennifer Kirley said:

I'm not aware of any requirement, except what the customer would dictate in a contract.

Based on some of the users manuals and assembly instructions I have reviewed, even if there was such a requirement it would not necessarily guarantee quality-- just like ISO 900X does not guarantee quality.

Click to expand...

This is the medical device forum and as such we answer to a higher authority. There are specific requirements for labeling of medical devices including the language which it is written. The user manual is part of the device labeling. BTW, I've attached a useless guidance document for translation.

If possible, send me the QSP to

Thanks
Athikesavan