米国輸出品に日本の添付文書を同梱できるか

米国輸出品に日本の添付文書を同梱しても良いか

あるセミナーで参加者から下記のような質問を受けた。よくある質問であるため共有したい。
「米国へ輸出する医療機器に日本の添付文書を同梱しても良いか？」

回答は、なるべく日本の添付文書を米国輸出品に挿入すべきではないということである。
ただし、推奨はできないが、同梱する日本の添付文書およびその他の日本語のラベル・ラベリングが米国のラベリング要求事項を満たしている場合、日本の添付文書の同梱も可能と考えられる。

包装表示に関しては、各国の情報（ラベルなど）が印刷されていても構わない。
例えば、本邦においては添付文書が電子化されるが、そのURLを印字していたとしても構わない。
ただし、米国向けであるラベル情報が目立つ（prominence）ようになっていなければならない。
また取扱説明書は、各国語で記載されていても構わない。
FDAのラベリングに関する規則であるPart 801 LABELINGには、下記のような記載がある。

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 authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.
ラベリングに外国語での表現が含まれている場合、法またはその権限の下で必要とされるラベルまたはラベリングに表示するすべての単語、ステートメント、およびその他の情報は、当該外国語によって表示されるものとする。

またFDAのラベリングガイドのp.6には以下の記述がある。
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.

関連商品

[blogcard url=”https://xn--2lwu4a.jp/qms-md/” title=”QMS（手順書）ひな形　医療機器関連” ]

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