Medical Device Labels and 21CFR part 801.15



Dear all,

We are a manufacturer of imaging system based in France and exporting our products around the world.
We would like to homogenize our labeling process and working for a new international template of label that will comply to all countries regulations.
The label will contain amongst others Chinese statements (to comply with the chinese requirements) and English ones (laser certification and FCC). The usability concerns (people cannot read specific information that do not apply to them) is addressed by the use of ISO 3166 country codes

To comply with 21 CFR part 801.15 C.2:
1. Do we have to translate the laser certification and FCC to Chinese and to all the other foreign languages that appear on the label?
2. Do we need to translate the Chinese certification, Japanese one to English?

Thank you for your feedback.


Re: Labels and 21CFR part 801.15

There is no coherent regulatory direction on this issue anywhere.

My view based on experience is, assuming that you indicate localization of different labeling elements, you do not have to translate every labeling element into every language. Many instances of labeling at the company for which I work contain USA-only elements, and sometimes other country-specific elements.
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