Chapter V Regulations on Machinery and Other Such Equipment, Dangerous Substances, and Harmful Substances (Articles 49 to 53-3)
The law as Act Partially Amending the Industrial Safety and Health Act and the Working Environment Measurement Act (Act No. 33 of 2025) leaves it, with the words it changes marked.
The main text is read a page at a time: a chapter to a page, and a long chapter in runs of articles. The whole main text, and the supplementary provisions and appended tables this amendment changes. Those it leaves untouched are on the page for the text in force.
Article 49第四十九条
Suspension and Discontinuance of Operations(業務の休廃止)
Article 49, paragraph (1)
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.
Provision and Inspection of Financial Statements(財務諸表等の備付け及び閲覧等)
Article 50, paragraph (1)
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
Article 50, paragraph (2), item (ii)
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
Article 50, paragraph (2), item (iii)
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;
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
Article 50, paragraph (3), item (iii)
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.
Notification of the Appointment or Dismissal of Reviewers or Inspectors(審査員又は検査員の選任等の届出)
Article 51, paragraph (1)
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.
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.
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.
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".
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:
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。
Article 53, paragraph (1), item (ii)
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。
Article 53, paragraph (1), item (iii)
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;
正当な理由がないのに第五十条第二項各号又は第三項各号の規定による請求を拒んだとき。
Article 53, paragraph (1), item (iv)
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。
Article 53, paragraph (1), item (v)
the agency has violated an order under the provisions of Article 52 or 52-2;
第五十二条又は第五十二条の二の規定による命令に違反したとき。
Article 53, paragraph (1), item (vi)
the agency has been registered by wrongful means.
不正の手段により登録を受けたとき。
Article 53, paragraph (2)
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:
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。
Article 53, paragraph (2), item (ii)
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;
前条において読み替えて準用する第五十二条又は第五十二条の二の規定による請求に応じなかつたとき。
Article 53, paragraph (2), item (iii)
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;
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;
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;
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。
Article 53, paragraph (3)
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.
Design Reviews or Post-Manufacturing Inspections by the Director of the Prefectural Labour Bureau(都道府県労働局長による設計審査等の実施)
Article 53-2, paragraph (1)
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.
Registered Agency for Performance Inspections(登録性能検査機関)
Article 53-3, paragraph (1)
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