Is it acceptable to include the Japanese attachment with U.S. exports?
I received the following question from a participant at a seminar. I would like to share it with you because it is a frequently asked question.
“May I include Japanese attachments with medical devices to be exported to the U.S.?”
The answer is that, as much as possible, Japanese attachments should not be inserted into U.S. exports.
However, although it is not recommended, it may be possible to include the Japanese attachment and other Japanese labeling if the Japanese attachment and other Japanese labeling included in the package meets the U.S. labeling requirements.
With regard to packaging labeling, information (e.g., labels) may be printed for each country.
For example, although the attached document will be electronic in Japan, it is acceptable if the URL is printed.
However, label information that is intended for the U.S. must be prominence.
Instruction manuals may also be written in different languages.
The FDA’s labeling regulations, Part 801 LABELING, contain the The following statement is included in the rule.
21 CFR Part 801.15
(c)(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under the authority of the act to appear on the label or labeling shall appear on the labeling in a foreign language.
If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under the authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language. All words, statements, and other information appearing on the label or labeling required under the Act or its authority shall appear in such foreign language.
Also, p. 6 of the FDA’s labeling guide contains the following statement
o All labeling shall be in English with the exception of products distributed solely within Puerto Rico or a U.S. territory where the predominant language is other than English.
In these instances the predominant language may be substituted for English.
– If any representation on the device label or labeling appears in a foreign language, then all required labeling shall also appear in that foreign language.
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