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 that item, 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").
specified machinery or other such equipment pertaining to the following machinery or other such equipment: design reviews and post-manufacturing inspections;
machinery or other such equipment set forth in item (i) or (ii) of Appended Table 1;
specified machinery or other such equipment pertaining to the following machinery or other such equipment: design reviews.
machinery or other such equipment set forth in item (iii) or (v) of Appended Table 1;
machinery or other such equipment set forth in item (vi) or (vii) of Appended Table 1.
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a person whose registration has been rescinded pursuant to the provisions of paragraph (1) or (2) of Article 53, if two years have not passed since the date of the rescission;
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:
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;
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;
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;
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;
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;
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):
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).
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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