Hi,

We are a medical software company, developing class II products.
We have our user manuals written in English, and like to translate these to Chinese (because we will start selling our products in China).

We have Chinese software developers in house (they speak both English and Chinese), who could do the translations.

The question: are there any regulatory objections to this? Are we required to have a professional translator do this? If not, what process should we use (review, etc.)

The background of the question: A possibly inaccurate translation might cause wrong usage of the application, and may put risks on patient safety.

Any suggestions are welcome!

Dajobimi.

We recently had our insert translated into Spanish and used a relativley inexpensive outside service and then had it checked essentially in-house by a second person. That way we coudl document that we did not rely solely on one person translating and it was not only employee-done but independent as well. We thought that this was enough due diligence.

Mike

Hi,

We are a medical software company, developing class II products.
We have our user manuals written in English, and like to translate these to Chinese (because we will start selling our products in China).

We have Chinese software developers in house (they speak both English and Chinese), who could do the translations.

The question: are there any regulatory objections to this? Are we required to have a professional translator do this? If not, what process should we use (review, etc.)

The background of the question: A possibly inaccurate translation might cause wrong usage of the application, and may put risks on patient safety.

Any suggestions are welcome!

Dajobimi.
The background of the question makes perfect sense, hence if I was you, I would approach an agency or a competant person, who has the required knowledge of the Chinese and English language to translate / review, and keep his credentials (like CV having info about his language proficiency, certifications etc.,) as evidence of evaluation and selection of this source for Chinese < -> English language review / translation requirements per clause 7.4.1. of the ISO 13485.

You could consider to have your employee translate it to Chinese and let an independant translator do the Chinese-English translation.

Review the differences between the original English version and the one that was created by translation to Chinese and back to English. This could validate your translation.

Rob.