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Article 46Registration of Registered Agencies for Design Reviews and Post-Manufacturing Inspections

第四十六条(登録設計審査等機関の登録)

The registration referred to in paragraph (3) of Article 37 (hereinafter in this Article, the following Article, paragraphs (1) and (2) of Article 53, and paragraph (1) of Article 53-2, referred to as a "registration") is made, pursuant to Order of the Ministry of Health, Labour and Welfare, for conducting the operations specified in each of the following items according to the category of specified machinery or other such equipment set forth in , for each regional classification prescribed by Order of the Ministry of Health, Labour and Welfare, at the application of a person seeking to conduct a design review or post-manufacturing inspection (hereinafter referred to as a "design review or post-manufacturing inspection").

第三十七条第三項の登録(以下この条、次条、第五十三条第一項及び第二項並びに第五十三条の二第一項において「登録」という。)は、厚生労働省令で定めるところにより、次の各号に掲げる特定機械等の区分に応じ当該各号に定める業務を行うことについて、厚生労働省令で定める地域の区分ごとに、設計審査又は製造時等検査(以下「設計審査等」という。)を行おうとする者の申請により行う。

A person falling under any of the following items may not be registered:

次の各号のいずれかに該当する者は、登録を受けることができない。

a person that has been sentenced to a fine or heavier punishment for violating the provisions of this Act or an order under this Act, if two years have not passed since the day on which the person finished serving the sentence or ceased to be subject to its enforcement;

この法律又はこれに基づく命令の規定に違反して、罰金以上の刑に処せられ、その執行を終わり、又は執行を受けることがなくなつた日から起算して二年を経過しない者

a person whose registration has been rescinded pursuant to the provisions of paragraph (1) or (2) of Article 53, if two years have not passed since the date of the rescission;

第五十三条第一項又は第二項の規定により登録を取り消され、その取消しの日から起算して二年を経過しない者

a corporation that has a person falling under one of the preceding two items as an officer engaged in its business operations.

法人で、その業務を行う役員のうちに前二号のいずれかに該当する者があるもの

The Minister of Health, Labour and Welfare must register a person that has applied for registration pursuant to the provisions of paragraph (1) (hereinafter referred to as the "registration applicant" in this paragraph), if the registration applicant satisfies all of the following requirements:

厚生労働大臣は、第一項の規定により登録を申請した者(以下この項において「登録申請者」という。)が次に掲げる要件の全てに適合しているときは、登録をしなければならない。

the number of persons implementing design reviews (restricted only to those who have knowledge and experience which meet one of the requirements set forth in item (i) of Appended Table 4-2; hereinafter each such person is referred to as a "reviewer") would be the figure shown in item (ii) of that Table or more;

設計審査を実施する者(別表第四の二第一号に掲げる条件のいずれかに適合する知識経験を有する者に限る。以下「審査員」という。)の数が同表第二号に掲げる数以上であること。

a reviewer with knowledge and experience that meet one of the requirements set forth in Appended Table 4-3 would instruct the reviewers and supervise the operations for design reviews;

審査員であつて別表第四の三に掲げる条件のいずれかに適合する知識経験を有するものが審査員を指揮するとともに設計審査の業務を管理するものであること。

for a person conducting post-manufacturing inspections, according to the category of machinery or other such equipment set forth in the left-hand column of Appended Table 5, it would conduct post-manufacturing inspections using the instruments and other equipment shown in the corresponding right-hand column of the Table;

製造時等検査を行う者にあつては、別表第五の上欄に掲げる機械等の区分に応じ、それぞれ同表の下欄に掲げる機械器具その他の設備を用いて製造時等検査を行うものであること。

for a person conducting post-manufacturing inspections, the number of persons implementing post-manufacturing inspections (restricted only to those who have knowledge and experience which meet one of the requirements set forth in item (i) of Appended Table 6; hereinafter each such person is referred to as an "inspector") would be the figure shown in item (ii) of that Table or more;

製造時等検査を行う者にあつては、製造時等検査を実施する者(別表第六第一号に掲げる条件のいずれかに適合する知識経験を有する者に限る。以下「検査員」という。)の数が同表第二号に掲げる数以上であること。

for a person conducting post-manufacturing inspections, an inspector with knowledge and experience that meet one of the requirements set forth in Appended Table 7 would instruct the inspectors and supervise the post-manufacturing inspections;

製造時等検査を行う者にあつては、検査員であつて別表第七に掲げる条件のいずれかに適合する知識経験を有するものが検査員を指揮するとともに製造時等検査の業務を管理するものであること。

the registration applicant does not fall under any of the following as a person that is controlled by a person manufacturing or importing specified machinery or other such equipment (hereinafter referred to as a "manufacturer or importer" in this item):

登録申請者が、特定機械等を製造し、又は輸入する者(以下この号において「製造者等」という。)に支配されているものとして次のいずれかに該当するものでないこと。

if the registration applicant is a stock company, and the manufacturer or importer is its parent company (meaning a parent company as prescribed in paragraph (1) of Article 879 of the Companies Act (Act No. 86 of 2005); and if the applicant is a person that seeks to carry out the operations for design reviews or post-manufacturing inspections at an office in a foreign country, this includes anything equivalent to a parent company as under that Act in that country).

登録申請者が株式会社である場合にあつては、製造者等がその親法人(会社法(平成十七年法律第八十六号)第八百七十九条第一項に規定する親法人をいい、当該登録申請者が外国にある事務所において設計審査等の業務を行おうとする者である場合にあつては、外国における同法の親法人に相当するものを含む。)であること。

the ratio of officers (for a membership company (meaning a membership company pursuant to paragraph (1) of Article 575 of the Companies Act), company members who execute the company business) or staff of the manufacturer or importer (including persons who have been officers or staff of the manufacturer or importer within the past two years) to officers of the registration applicant exceeds one half.

登録申請者の役員(持分会社(会社法第五百七十五条第一項に規定する持分会社をいう。)にあつては、業務を執行する社員)に占める製造者等の役員又は職員(過去二年間に当該製造者等の役員又は職員であつた者を含む。)の割合が二分の一を超えていること。

the registration applicant (or an officer with the authority to represent it, if the applicant is a corporation) is an officer or employee of the manufacturer or importer (including persons who have been officers or employees of the manufacturer or importer within the past two years).

登録申請者(法人にあつては、その代表権を有する役員)が、製造者等の役員又は職員(過去二年間に当該製造者等の役員又は職員であつた者を含む。)であること。

The relevant person is to make a registration by entering the following items in the register of the registered agency for design reviews and post-manufacturing inspections:

登録は、登録設計審査等機関登録簿に次に掲げる事項を記載してするものとする。

date and number of registration;

登録年月日及び登録番号

name and address, and if it is a corporation, the name of its representative;

氏名又は名称及び住所並びに法人にあつては、その代表者の氏名

name and address of the office;

事務所の名称及び所在地

its category as referred to in paragraph (1).

第一項の区分

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