Article 44-3Valid Term of Type Examination Certificates
第四十四条の三（型式検定合格証の有効期間等）
The valid term of a type examination certificate (or, if the valid term of a type examination certificate is renewed pursuant to the provisions of the following paragraph, the valid term of the examination certificate as renewed) is the period specified by Order of the Ministry of Health, Labour and Welfare in line with the kind of machinery or other such equipment referred to in the main text of paragraph (1) of the preceding Article.
A person seeking a renewal of the valid term of a type examination certificate must undergo a type examination pursuant to Order of the Ministry of Health, Labour and Welfare.
型式検定合格証の有効期間の更新を受けようとする者は、厚生労働省令で定めるところにより、型式検定を受けなければならない。
Article 44-4Invalidation of Type Examination Certificates
第四十四条の四（型式検定合格証の失効）
If machinery or other such equipment falls under any of the following items, the Minister of Health, Labour and Welfare may invalidate the type examination certificate associated with the machinery or other such equipment referred to in that item (the type examination certificate issued to the foreign manufacturer, for item (ii)):
f the construction of machinery or other such equipment of the type for which the relevant person has passed a type examination, or equipment or other things for manufacturing and inspecting that machinery or other such equipment is found not to be in conformity with the standards specified by Order of the Ministry of Health, Labour and Welfare that are referred to in paragraph (3) of Article 44-2;
型式検定に合格した型式の機械等の構造又は当該機械等を製造し、若しくは検査する設備等が第四十四条の二第三項の厚生労働省令で定める基準に適合していないと認められるとき。
a foreign manufacturer that has undergone a type examination has affixed a label as referred to in paragraph (5) of Article 44-2 or one that is misleadingly similar thereto to machinery or other such equipment imported into Japan which is other than the type of machinery or other such equipment for which that person has passed that type examination;
型式検定を受けた外国製造者が、当該型式検定に合格した型式の機械等以外の機械等で本邦に輸入されたものに、第四十四条の二第五項の表示を付し、又はこれと紛らわしい表示を付しているとき。
If on finding it to be necessary to do so in order to ensure safety and health of the workers with regard to the construction of machinery or other such equipment of the type for which the relevant person has passed a type examination and equipment or other things for manufacturing and inspecting that machinery or other such equipment,the Minister has had the relevant officials enter the workplace of the person that has undergone the type examination or the place where the machinery or other such equipment or facilities or other things connected to the type examination are found to be located, question person concerned, and other article, but no statement or a false statement has been given inresponse to those questions or the inspection has been refused, hindered or aboided.
Article 45Periodic Inspections
第四十五条（定期自主検査）
An employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must conduct inspections periodically and keep the records of the results on boilers and machinery or other such equipment that is specified by Cabinet Order.
If undertaking any inspection under the provisions of the preceding paragraph for machinery or other such equipment specified by Cabinet Order as referred to in that paragraph, that is specified by Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as a "specified inspection"), an employer that constitutes a person with the qualifications specified by Order of the Ministry of Health, Labour and Welfare (or, if the employer is a corporation, its representative or officer that constitutes such a person) must implement this itself, or the employer must have this implemented by a worker it employs who constitutes a person with the qualifications specified by that Order of the Ministry of Health, Labour and Welfare or by a person registered as prescribed in Article 54-3, paragraph (1) to carry out specified inspections of the relevant machinery or other such equipment at the request of other persons (hereinafter referred to as a "registered inspection agency").
Specified inspections must be conducted in accordance with the standards specified by the Minister of Health, Labour and Welfare.
特定自主検査は、厚生労働大臣の定める基準に従つて行わなければならない。
The Minister of Health, Labour and Welfare must release the necessary guidelines for inspections to ensure the appropriate and effective implementation of inspections under the provisions of paragraph (1) (excluding specified inspections).
Having released guidelines for inspections as referred to in the preceding paragraph, and on finding that it is necessary to do so, the Minister of Health, Labour and Welfare may provide the necessary guidance on those guidelines for inspections to employers, registered inspection agencies, and associations thereof.
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
Article 46-2Renewal of Registrations
第四十六条の二（登録の更新）
If not renewed for every five- to ten- year period specified by Cabinet Order, a registration ceases to be effective upon the expiration of that period..
登録は、五年以上十年以内において政令で定める期間ごとにその更新を受けなければ、その期間の経過によつて、その効力を失う。
The provisions of paragraphs (2) through (4) apply mutatis mutandis to the renewal of a registration referred to in the preceding paragraph.
前条第二項から第四項までの規定は、前項の登録の更新について準用する。
If requested to conduct a design review or post-manufacturing inspection, a registered agency for design reviews and post-manufacturing inspections must conduct a design review or post-manufacturing inspection without delay unless it has a legitimate reason not to do so.
A registered agency for design reviews and post-manufacturing inspections must, in conducting design reviews, have these implemented by reviewers, and, in conducting post-manufacturing inspections, have these implemented by inspectors.
A registered agency for design reviews and post-manufacturing inspections must conduct design reviews or post-manufacturing inspections fairly and in accordance with the part of the standards referred to in paragraph (2) of Article 37 that relates to construction and the methods specified by the Minister of Health, Labour and Welfare.
When conducting post-manufacturing inspections, a registered agency for design reviews and post-manufacturing inspections must take measures that Order of the Ministry of Health, Labour and Welfare prescribes as the necessary measures to prevent danger from arising from an inspection method in a post-manufacturing inspection.
Article 47-2Notification of Alteration
第四十七条の二（変更の届出）
A registered agency for design reviews and post-manufacturing inspections that has altered a particular referred to in item (ii) or (iii) of paragraph (4) of Article 46 must file a notification of the alteration with the Minister of Health, Labour and Welfare within two weeks from the date of the alteration.
登録設計審査等機関は、第四十六条第四項第二号又は第三号の事項を変更したときは、変更の日から二週間以内に、厚生労働大臣に届け出なければならない。
第四十八条（業務規程）
A registered agency for design reviews and post-manufacturing inspections must establish rules concerning the operations for design reviews or post-manufacturing inspections (hereinafter referred to as "operational rules"), and must file a notification of those operational rules with the Minister of Health, Labour and Welfare by two weeks prior to the day of the commencement of the operations for design reviews or post-manufacturing inspections. The same applies if it seeks to alter them.
The operational rules must specify the means of implementing design reviews or post-manufacturing inspections, the fees associated with design reviews or post-manufacturing inspections, and other particulars prescribed in Order of the Ministry of Health, Labour and Welfare.
Before suspending or discontinuing all or a part of its operations for design reviews or post-manufacturing inspections, a registered agency for design reviews and post-manufacturing inspections, pursuant to Order of the Ministry of Health, Labour and Welfare, must first file a notification of this with the Minister of Health, Labour and Welfare.