Article 50Provision and Inspection of Financial Statements
第五十条（財務諸表等の備付け及び閲覧等）
Within three months after the end of each business year, a registered agency for design reviews and post-manufacturing inspections must prepare an inventory of assets, a balance sheet and a profit and loss statement or an income and expenditure statement, and a business report for the business year (including electronic or magnetic records (meaning records used in computerized data processing that have been created electronically, magnetically, or by another means that cannot be perceived with the human senses; the same applies hereinafter), if electronic or magnetic records are prepared instead of paper documents; referred to as "financial statements, etc." in the following paragraph and in item (i) of Article 123), and must retain those financial statements, etc. for five years thereafter in its office.
A person seeking to undergo a design review or post-manufacturing inspection or any other interested person may make the following requests at any time during the office hours of a registered agency for design reviews and post-manufacturing inspections; provided, however, that for a request as referred to in item (ii) or (iv), a person must pay the cost established by the agency:
a request to inspect or copy the relevant document, if a financial statement has been prepared as a written document;
財務諸表等が書面をもつて作成されているときは、当該書面の閲覧又は謄写の請求
a request for a certified copy or extract of the document referred to in the previous item;
前号の書面の謄本又は抄本の請求
a request to inspect or copy something that has been made to show the information recorded in the relevant electronic or magnetic record by the means specified by Order of the Ministry of Health, Labour and Welfare, if a financial statement has been prepared as an electronic or magnetic record;
a request to be provided with the information recorded in an electronic or magnetic record as referred to in the previous item by an electronic or magnetic means that is specified by Order of the Ministry of Health, Labour and Welfare, or to be issued a written document giving that information.
If a registered agency for design reviews and post-manufacturing inspections has entered into an insurance contract to guarantee the money necessary to compensate for any damage occurring in connection with a design review or post-manufacturing inspection (hereinafter referred to as a "non-life insurance policy" in this paragraph), a person seeking to undergo a design review or post-manufacturing inspection or any other interested person may make the following requests at any time during the office hours of the registered agency for design reviews and post-manufacturing inspections; provided, however, that for a request as referred to in item (ii) or (iv), a person must pay the cost established by the agency:
a request to inspect or copy the relevant document, if the documentation detailing the substance of the non-life insurance policy has been prepared as a written document;
損害保険契約の契約内容を記載した書類が書面をもつて作成されているときは、当該書面の閲覧又は謄写の請求
a request for a certified copy or extract of the document referred to in the previous item;
前号の書面の謄本又は抄本の請求
a request to inspect or copy something that has been made to show the information recorded in the relevant electronic or magnetic record by the means specified by Order of the Ministry of Health, Labour and Welfare, if the document referred to in item (i) above has been prepared as an electronic or magnetic record;
a request to be provided with the information recorded in an electronic or magnetic record as referred to in the previous item by an electronic or magnetic means that is specified by Order of the Ministry of Health, Labour and Welfare, or to be issued a written document giving that information.
A registered agency for design reviews and post-manufacturing inspections must submit a profit and loss statement or an income and expenditure statement, and a business report for each business year that are prepared pursuant to the provisions of paragraph (1) to the Minister of Health, Labour and Welfare within three months after the end of that business year.
Article 51Notification of the Appointment or Dismissal of Reviewers or Inspectors
第五十一条（審査員又は検査員の選任等の届出）
Having appointed or dismissed a reviewer or an inspector, a registered agency for design reviews and post-manufacturing inspections must file a notification of this with the Minister of Health, Labour and Welfare, pursuant to Order of the Ministry of Health, Labour and Welfare and without delay.
第五十二条（適合命令）
On finding that a registered agency for design reviews and post-manufacturing inspections (excluding a registered agency for design reviews and post-manufacturing inspections that carries out the operations for design reviews or post-manufacturing inspections at offices in foreign countries (hereinafter referred to as a "foreign registered agency for design reviews and post-manufacturing inspections")) has ceased to comply with the standards prescribed in any item of paragraph (3) of Article 46, the Minister of Health, Labour and Welfare may order the agency to take the necessary measures to conform to those standards.
Article 52-2Order for Improvement
第五十二条の二（改善命令）
Having found that a registered agency for design reviews and post-manufacturing inspections (excluding a foreign registered agency for design reviews and post-manufacturing inspections) has violated the provisions of Article 47, the Minister of Health, Labour and Welfare may order the agency to carry out a design review or post-manufacturing inspection, or to take the necessary measures to improve the methods of design reviews or post-manufacturing inspections or other business methods.
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。）が第四十七条の規定に違反していると認めるときは、その登録設計審査等機関に対し、設計審査等を行うべきこと又は設計審査等の方法その他の業務の方法の改善に関し必要な措置をとるべきことを命ずることができる。
Article 52-3Application Mutatis Mutandis
第五十二条の三（準用）
The provisions of the preceding two Articles apply mutatis mutandis to a foreign registered agency for design reviews and post-manufacturing inspections. In such a case, the term "order" in the preceding two Articles is deemed to be replaced with "request".
前二条の規定は、外国登録設計審査等機関について準用する。この場合において、前二条中「命ずる」とあるのは、「請求する」と読み替えるものとする。
Article 53Cancellation of Registrations
第五十三条（登録の取消し等）
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。
第五十三条の二（都道府県労働局長による設計審査等の実施）
The Director of the Prefectural Labour Bureau may directly conduct all or a part of the relevant operations for design reviews or post-manufacturing inspections if there is no person registered to do so; on having received a notification under the provisions of Article 49 of the suspension or discontinuation of all or part of the operations for design reviews or post-manufacturing inspections; on having revoked a registration or issued an order to a registered agency for design reviews and post-manufacturing inspections to suspend all or part of its operations for design reviews or post-manufacturing inspections pursuant to paragraph (1) or (2) of the preceding Article; if it has become difficult for a registered agency for design reviews and post-manufacturing inspections to carry out all or part of its operations for design reviews or post-manufacturing inspections due to a natural disaster or other cause; or on otherwise finding it to be necessary to do so.
Order of the Ministry of Health, Labour and Welfare provides for the taking on of the operations for design reviews or post-manufacturing inspections and other necessary particulars if the Director of the Prefectural Labour Bureau directly carries out all or part of the operations for design reviews or post-manufacturing inspections pursuant to the provisions of the preceding paragraph.
Article 53-3Registered Agency for Performance Inspections
第五十三条の三（登録性能検査機関）
The provisions of Article 46 (excluding paragraph (1) (limited to the part concerning its items) and paragraph (3) (limited to the part concerning items (i) and (ii))) and Article 46-2 apply mutatis mutandis to the registration referred to in paragraph (2) of Article 41, and the provisions of Article 47 through the preceding Article apply mutatis mutandis to a registered agency for performance inspections. In such a case, beyond the term "design review or post-manufacturing inspection" in the provisions of Article 47 (including its caption) through Article 50 and of the preceding Article (including its caption) being deemed to be replaced with "performance inspection", and the term "foreign registered agency for design reviews and post-manufacturing inspections" in the provisions of Article 52 through Article 53 being deemed to be replaced with "foreign registered agency for performance inspections", the terms in the provisions set forth in the left-hand column of the following table that are set forth in the middle column of that table are deemed to be replaced with the terms set forth in the corresponding right-hand column of that table.
| paragraph (1) of Article 46 | paragraph (3) of Article 37 | paragraph (2) of Article 41 |
| 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 | for each classification prescribed by Order of the Ministry of Health, Labour and Welfare | |
| a design review or post-manufacturing inspection (hereinafter referred to as a "design review or post-manufacturing inspection") | a performance inspection referred to in paragraph (2) of Article 41 (hereinafter referred to as a "performance inspection") | |
| item (iii) of paragraph (3) of Article 46 | 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 | according to the category of machinery or other such equipment set forth in the left-hand column of Appended Table 8 |
| it would conduct post-manufacturing inspections | it would conduct performance inspections | |
| item (iv) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, the number of persons implementing post-manufacturing inspections | according to the machinery or other such equipment set forth in the left-hand column of Appended Table 9, the number of persons implementing performance inspections |
| item (i) of Appended Table 6 | the middle column of that Table | |
| item (ii) of that Table | the right-hand column of that Table | |
| item (v) of paragraph (3) of Article 46 | for a person conducting post-manufacturing inspections, an inspector | an inspector |
| Appended Table 7 | Appended Table 10 | |
| supervise the post-manufacturing inspections | supervise the performance inspections | |
| item (vi) of paragraph (3) of Article 46 | a person manufacturing or importing specified machinery or other such equipment | a person manufacturing or importing specified machinery or other such equipment or a person engaged in the business of maintaining specified machinery or other such equipment |
| design reviews or post-manufacturing inspections | performance inspections | |
| paragraph (4) of Article 46 | register of the registered agency for design reviews and post-manufacturing inspections | register of the registered agency for performance inspections |
| paragraph (2) of Article 47 | in conducting design reviews, have these implemented by reviewers, and, in conducting post-manufacturing inspections, | in conducting performance inspections, |
| paragraph (4) of Article 47 | post-manufacturing inspection | performance inspection |
| Article 49 | must first file a notification of this with the Minister of Health, Labour and Welfare | must file a notification of this with the Minister of Health, Labour and Welfare no later than 30 days prior to the date of suspension or discontinuance |
| Article 51 (including its caption) | a reviewer or an inspector | an inspector |
| Article 52 | design reviews or post-manufacturing inspections | performance inspections |
| Article 52-2 | a design review or post-manufacturing inspection | a performance inspection |
| the methods of design reviews or post-manufacturing inspections | the methods of performance inspections | |
| paragraph (1) and item (iii) of paragraph (2) of Article 53 | operations for design reviews or post-manufacturing inspections | operations for performance inspections |
| the preceding Article (including its caption) | Director of the Prefectural Labour Bureau | Chief of the Labour Standard Inspection Offices |
第四十六条（第一項（各号に係る部分に限る。）及び第三項（第一号及び第二号に係る部分に限る。）を除く。）及び第四十六条の二の規定は第四十一条第二項の登録について、第四十七条から前条までの規定は登録性能検査機関について準用する。この場合において、第四十七条（見出しを含む。）から第五十条まで及び前条（見出しを含む。）の規定中「設計審査等」とあるのは「性能検査」と、第五十二条から第五十三条までの規定中「外国登録設計審査等機関」とあるのは「外国登録性能検査機関」と読み替えるほか、次の表の上欄に掲げる規定中同表の中欄に掲げる字句は、それぞれ同表の下欄に掲げる字句に読み替えるものとする。
| 第四十六条第一項 | 第三十七条第三項 | 第四十一条第二項 |
| 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 | 厚生労働省令で定める区分 | |
| 設計審査又は製造時等検査（以下「設計審査等」という。） | 第四十一条第二項の性能検査（以下「性能検査」という。） | |
| 第四十六条第三項第三号 | 製造時等検査を行う者にあつては、別表第五 | 別表第八 |
| 製造時等検査を行うもの | 性能検査を行うもの | |
| 第四十六条第三項第四号 | 製造時等検査を行う者にあつては、製造時等検査 | 別表第九の上欄に掲げる機械等に応じ、性能検査 |
| 別表第六第一号 | 同表の中欄 | |
| 同表第二号 | 同表の下欄 | |
| 第四十六条第三項第五号 | 製造時等検査を行う者にあつては、検査員 | 検査員 |
| 別表第七 | 別表第十 | |
| 製造時等検査の | 性能検査の | |
| 第四十六条第三項第六号 | 又は輸入する者 | 若しくは輸入する者又は特定機械等の整備を業とする者 |
| 設計審査等 | 性能検査 | |
| 第四十六条第四項 | 登録設計審査等機関登録簿 | 登録性能検査機関登録簿 |
| 第四十七条第二項 | 設計審査を行うときは審査員にこれを実施させ、製造時等検査を行うときは | 性能検査を行うときは、 |
| 第四十七条第四項 | 製造時等検査 | 性能検査 |
| 第四十九条 | あらかじめ | 休止又は廃止の日の三十日前までに |
| 第五十一条（見出しを含む。） | 審査員又は検査員 | 検査員 |
| 第五十二条 | 設計審査等の | 性能検査の |
| 第五十二条の二 | 設計審査等を | 性能検査を |
| 設計審査等の | 性能検査の | |
| 第五十三条第一項及び第二項第三号 | 設計審査等の | 性能検査の |
| 前条（見出しを含む。） | 都道府県労働局長 | 労働基準監督署長 |