If a registered agency for design reviews and post-manufacturing inspections (excluding a foreign registered agency for design reviews and post-manufacturing inspections) has come to fall under one of the following items, the Minister of Health, Labour and Welfare may rescind its registration or order the suspension of all or part of its operations for design reviews or post-manufacturing inspections, for a fixed period not exceeding six months:
厚生労働大臣は、登録設計審査等機関（外国登録設計審査等機関を除く。）が次の各号のいずれかに該当するに至つたときは、その登録を取り消し、又は六月を超えない範囲内で期間を定めて設計審査等の業務の全部若しくは一部の停止を命ずることができる。
the agency has come to fall under item (i) or item (iii) of paragraph (2) of Article 46;
第四十六条第二項第一号又は第三号に該当するに至つたとき。
the agency has violated the provisions of Article 47 to 49, paragraph (1) or (4) of Article 50 or paragraph (2) of Article 103;
第四十七条から第四十九条まで、第五十条第一項若しくは第四項又は第百三条第二項の規定に違反したとき。
the agency has refused a request under the provisions of any item of paragraph (2), or any item in paragraph (3), of Article 50 without a legitimate reason for doing so;
the agency has failed to submit the notification under the provisions of Article 51 or submitted a false notification;
第五十一条の規定による届出をせず、又は虚偽の届出をしたとき。
the agency has violated an order under the provisions of Article 52 or 52-2;
the agency has been registered by wrongful means.
不正の手段により登録を受けたとき。
If a foreign registered agency for design reviews and post-manufacturing inspections has come to fall under any of the following items, the Minister of Health, Labour and Welfare may rescind its registration:
厚生労働大臣は、外国登録設計審査等機関が次の各号のいずれかに該当するに至つたときは、その登録を取り消すことができる。
the agency falls under any of items (i) through (iv) or item (vi) of the preceding paragraph;
前項第一号から第四号まで又は第六号のいずれかに該当するとき。
the agency has refused to comply with a request under the provisions of Article 52 or 52-2 as applied mutatis mutandis pursuant to the preceding Article;
the Minister of Health, Labour and Welfare has found the foreign registered agency for design reviews and post-manufacturing inspections to fall under one of the two preceding items and has requested it to suspend all or part of its operations for design reviews or post-manufacturing inspections for a specified period not exceeding six months, but it has not complied with that request;
厚生労働大臣が、外国登録設計審査等機関が前二号のいずれかに該当すると認めて、六月を超えない範囲内で期間を定めて設計審査等の業務の全部又は一部の停止を請求した場合において、その請求に応じなかつたとき。
the Minister of Health, Labour and Welfare, finding it to be necessary to do so in order to ensure the proper operation of a foreign registered agency for design reviews and post-manufacturing inspections, has had relevant officials seek to enter the agency's office, question the persons concerned or inspect books, documents and other articles related to the operations, but the agency has refused, impeded, or hindered their entrance or inspection, or has refused to answer or given false answers to their questions;
厚生労働大臣が、外国登録設計審査等機関の業務の適正な運営を確保するため必要があると認めて、その職員をして外国登録設計審査等機関の事務所に立ち入らせ、関係者に質問させ、又はその業務に関係のある帳簿、書類その他の物件を検査させようとした場合において、その立入り若しくは検査が拒まれ、妨げられ、若しくは忌避され、又は質問に対して陳述がされず、若しくは虚偽の陳述がされたとき。
the Minister of Health, Labour and Welfare, finding it to be necessary to do so in order to enforce this Act, requests a foreign registered agency for design reviews and post-manufacturing inspections to report the necessary particulars, but the agency has not made this report or has made a false report;
厚生労働大臣が、この法律を施行するため必要があると認めて、外国登録設計審査等機関に対し、必要な事項の報告を求めた場合において、その報告がされず、又は虚偽の報告がされたとき。
the agency fails to bear the expenses under the provisions of the following paragraph.
次項の規定による費用の負担をしないとき。
The expenses required for the inspection pursuant to item (iv) of the preceding paragraph (limited to those which are specified by Cabinet Order) are borne by the foreign registered agency for design reviews and post-manufacturing inspections that is subject to the inspection.
前項第四号の検査に要する費用（政令で定めるものに限る。）は、当該検査を受ける外国登録設計審査等機関の負担とする。
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