Industrial Safety and Health Act

The purpose of this Act is to ensure workers' safety and health in the workplace and to facilitate the creation of comfortable work environments, by advancing comprehensive and systematic measures related to industrial injury prevention, such as the taking of measures to establish standards for hazard prevention, clarifying accountability structures, and promoting autonomous action with a view to preventing industrial injuries, in conjunction with the Labor Standards Act (Act No. 49 of 1947).

In this Act, the meanings of the terms set forth in the following items are as prescribed in those items:

①Not only must an employer comply with the minimum standards for preventing industrial injuries provided for in this Act, but it must also work to ensure the safety and health of workers in the workplace through the creation of a comfortable work environment and the improvement of working conditions. Furthermore, an employer must work to cooperate with government-implemented policies for preventing industrial injuries.

②A person that designs, manufactures, or imports the machinery, tools, or other equipment; that manufactures or imports raw materials; or that constructs or designs constructions; must endeavor, in designing, manufacturing, importing or constructing them, to contribute to preventing the occurrence of industrial injuries caused by their use.

③A person, such as an orderer of construction work, that contracts out a job to another person must take care that it does not attach conditions, regarding things such as construction techniques, work methods, the construction period and the delivery date, that could impede the safe and healthy performance of the work.

In addition to observing the necessary particulars to prevent industrial injuries, a worker, and a person other than a worker who is engaged in work on a job at the same site as workers, must also endeavor to cooperate with measures to prevent industrial injuries that the employer and related parties implement.

①If two or more employers with business undertakings in the construction industry have been contracted to work together jointly on a job that is involved in those undertakings that will be carried out at one site, they must designate one person from among themselves as a representative and file a notification of this with the Director of the Prefectural Labour Bureau, pursuant to Order of the Ministry of Health, Labour and Welfare .

②If a notification under the provisions of the preceding paragraph has not been filed, the Director of the Prefectural Labour Bureau designates a representative.

③A change to the representative referred to in the preceding two paragraphs does not become valid unless a notification is filed with the Director of the Prefectural Labour Bureau.

④In a case as provided in paragraph (1), this Act is applied by deeming the relevant business undertakings to be the undertakings of the representative referred to in paragraph (1) or (2) alone, the representative alone to be the employer in those undertakings, and the workers engaged in the jobs involved in those undertakings to be workers employed solely by the representative.

After hearing the opinion of the Labor Policy Council, the Minister of Health, Labour and Welfare must formulate a plan prescribing the particulars of the main measures to prevent industrial injuries and providing for other material particulars concerning the prevention of industrial injuries (hereinafter referred to as the "Industrial Injury Prevention Plan").

On finding it to be necessary to do so in consideration of the situation surrounding the occurrence of industrial injuries, the effect of measures to prevent industrial injuries, and other factors, the Minister of Health, Labour and Welfare must change the Industrial Injury Prevention Plan, after hearing the opinion of the Labor Policy Council.

The Minister of Health, Labour and Welfare must make the Industrial Injury Prevention Plan public without delay after it is formulated. The same applies if the minister changes the plan.

On finding it to be necessary to do so for the reliable and smooth implementation of the Industrial Injury Prevention Plan, the Minister of Health, Labour and Welfare may issue the necessary recommendations or requests regarding particulars that concern the prevention of industrial injuries to persons conducting a business, their organizations, and other related parties.

①At each workplace of the scale specified by Cabinet Order, an employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must appoint a general safety and health manager and have that person direct the work of safety managers, health managers, and persons managing technical issues pursuant to the provisions of paragraph (2) of Article 25-2, as well as having that person engage in the overall management of the following operations:

②The position of general safety and health manager must be filled by the person in charge of overall management for implementing the undertaking at the relevant workplace.

③On finding it to be necessary to do so in order to prevent an industrial injury, the Director of the Prefectural Labour Bureau may issue recommendations to an employer regarding the professional performance of a general safety and health manager.

①At each workplace of the business type and scale specified by Cabinet Order, an employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must appoint a safety manager from among persons holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare, and have the safety manager manage the technical issues related to safety that are among the operations set forth in each item of paragraph (1) of the preceding Article (excluding operations that constitute the measures referred to in any of the items of paragraph (1) of the Article 25-2, if a person in charge of managing technical issues is appointed pursuant to the provisions of paragraph (2) of that Article).

②On finding it to be necessary to do so in order to prevent an industrial injury, the Chief of the Labour Standard Inspection Offices may order an employer to increase the number of safety managers or dismiss the current safety manager.

①At each workplace of the scale specified by Cabinet Order, an employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must appoint a health manager for the category of operations at that workplace, from among persons licensed by the Director of the Prefectural Labour Bureau or otherwise holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare and have the health manager manage the technical issues related to health that are among the operations set forth in each item of paragraph (1) of Article 10 (excluding operations that constitute the measures set forth in any of the items of paragraph (1) of Article 25-2, if a person in charge of managing technical issues is appointed pursuant to the provisions of paragraph (2) of that Article).

②The provisions of paragraph (2) of the preceding Article apply mutatis mutandis to health managers.

At a workplace, other than one as referred to in paragraph (1) of Article 11 and paragraph (1) of the preceding Article, that is of the scale specified by Order of the Ministry of Health, Labour and Welfare, an employer must appoint a safety and health advocate (or a health advocate, for workplaces of a business type other than those specified by Cabinet Order as referred to in paragraph (1) of Article 11) and have that person take charge of the operations referred to in the items of paragraph (1) of Article 10 (excluding operations that constitute the measures referred to in any of the items of paragraph (1) of Article 25-2, if a person in charge of managing technical issues is appointed pursuant to the provisions of paragraph (2) of that Article; at a workplace of a business type other than those specific by Cabinet Order as referred to in Article 11, paragraph (1), this is limited to operations involving health).

①At each workplace of the scale specified by Cabinet Order, an employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must appoint a medical doctor as an industrial physician and have that person provide healthcare to workers and undertake other duties specified by Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as "worker healthcare and related duties").

②An industrial physician must be a person who meets the requirements specified by Order of the Ministry of Health, Labour and Welfare concerning the medical knowledge that a person needs to have in order to undertake worker healthcare and related duties.

③An industrial physician must undertake the duties thereof in good faith based on having the medical knowledge needed to undertake worker healthcare and related duties.

④An employer that has appointed an industrial physician must provide the industrial physician, pursuant to Order of the Ministry of Health, Labour and Welfare, with information on workers' working hours and other information provided by Order of the Ministry of Health, Labour and Welfare that the industrial physician needs in order to properly undertake worker healthcare and related duties.

⑤On finding it to be necessary to do so in order to ensure the health of a worker, an industrial physician may issue the necessary recommendations regarding worker healthcare and related duties to the employer. In such a case, the employer must respect these recommendations.

⑥Having received a recommendation referred to in the preceding paragraph, an employer must report the substance of the recommendation and other particulars prescribed by Order of the Ministry of Health, Labour and Welfare to the health committee or safety and health committee pursuant to Order of the Ministry of Health, Labour and Welfare.

①An employer must endeavor to have a physician having the medical knowledge that a person needs to have in order to undertake worker healthcare and related duties or a person specified by Order of the Ministry of Health, Labour and Welfare undertake all or a part of the worker healthcare and related duties at a workplace other than one as referred to in paragraph (1) of the preceding Article.

②The provisions of paragraph (4) of the preceding Article apply mutatis mutandis to an employer that has a person as prescribed in the preceding paragraph undertake all or a part of worker healthcare and related duties. In such a case, the phrase "must provide" in paragraph (4) of that Article is deemed to be replaced with "must endeavor to provide".

To enable an industrial physician or a person as prescribed in paragraph (1) of the preceding Article to properly implement worker healthcare and related duties, an employer must endeavor to take the necessary measures, such as developing the necessary framework for an industrial physician or a person as prescribed in that paragraph to respond properly to requests for health consultations from workers.

For work inside hyperbaric chambers and other work that makes it necessary to have in place controls for preventing industrial injuries, and that is specified by Cabinet Order, the employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must appoint an operations supervisor for the relevant work classification from among persons licensed by the Director of the Prefectural Labour Bureau and persons who have completed a skill training course conducted by a person registered by the Director of the Prefectural Labour Bureau, and have that person direct the employees engaged in the relevant work and undertake the other things that are specified by Order of the Ministry of Health, Labour and Welfare.

①An employer that has contracted out to a contractor a part of the job involved in a business undertaking it carries out at a single site (if there are two or more such contractors due to there being two or more contracts for work under which that part of the job involved in the undertaking is contracted out, this means the orderer under the earliest of those contracts; hereinafter referred to as the "principal employer"), and that has a business undertaking categorized as the construction industry or in any other industry specified by Cabinet Order (hereinafter referred to as a "specified undertaking") (hereinafter such an employer is referred to as a "specified principal employer") must appoint a general safety and health supervisor and have that person give directions to the principal safety and health manager, as well as having that person handle the overall management of the things referred to in the items of Article 30, paragraph (1), if, at that single site, both the persons engaged in work (meaning persons engaged in work on a job carried out by a person conducting a business; the same applies hereinafter) who are its workers (including, if there are persons engaged in work associated with the specified principal employer who are not workers in addition to the persons engaged in work who are its workers, those persons) and the persons engaged in work associated with its contractor (and with all subcontractors, if the job involved in the undertaking of the principal employer is carried out based on multiple levels of contracts; hereinafter referred to as "related contractors") work, in order to prevent industrial injuries from occurring as a result of the work of those persons engaged in work being carried out at the same site; provided, however, that this does not apply if the number of those persons engaged in work is less than the number specified by Cabinet Order.

②The position of general safety and health supervisor must be filled by the person in charge of overall management for implementing the undertaking at the relevant site.

③In a case as referred to in paragraph (4) of Article 30, if the total number of persons engaged in work as referred to in that paragraph is the number specified by Cabinet Order or more, the relevant designated employer, with regard to those persons engaged in work, must appoint a general safety and health supervisor in order to prevent industrial injuries from occurring as a result of the work of those persons engaged in work being carried out at the same site, must have that person direct the work of the principal safety and health manager, and must also have that person handle the overall management of the things referred to in the items of paragraph (1) of Article 30. In such a case, the provisions of paragraph (1) do not apply to the designated employer and to employers other than the designated employer.

④Beyond as prescribed in paragraph (1) and the preceding paragraph, if a job as prescribed in paragraph (1) of Article 25-2 is carried out based on multiple levels of contracts, an employer appointing a general safety and health supervisor pursuant to paragraph (1) or the preceding paragraph, must have the general safety and health supervisor direct the work of persons in charge of managing technical issues pursuant to the provisions of paragraph (2) of Article 25-2 as they apply mutatis mutandis pursuant to paragraph (5) of Article 30-3, as well as having that person exercise overall control over the measures provided for in each item of paragraph (1) of Article 25-2.

⑤The provisions of paragraph (3) of Article 10 apply mutatis mutandis to the execution of operations by the general safety and health supervisor. In such a case, the term "an employer" in that paragraph is deemed to be replaced with "the employer that has appointed the general safety and health supervisor".

①Pursuant to Order of the Ministry of Health, Labour and Welfare, an employer that has appointed a general safety and health supervisor pursuant to the provisions of paragraph (1) or (3) of the preceding Article and that has a business undertaking categorized as the construction industry or in any other industry specified by Cabinet Order must appoint a principal safety and health manager from among persons holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare, and have that person manage the technical issues that are among the things set forth in the items of paragraph (1) of Article 30.

②The provisions of paragraph (2) of Article 11 apply mutatis mutandis to the principal safety and health manager. In such a case, the term "the employer" in that paragraph is deemed to be replaced with "the employer that has appointed the principal safety and health manager".

①When the persons engaged in work who are the workers of a principal employer with a business undertaking categorized as the construction industry (including, if there are persons engaged in work associated with the principal employer who are not workers in addition to the persons engaged in work who are its workers, those persons) and the persons engaged in work associated with a related contractor carry out work at one site (excluding sites where the number of those persons engaged in work is less than the number specified by Order of the Ministry of Health, Labour and Welfare and locations where a general safety and health supervisor must be appointed pursuant to the provisions of paragraph (1) or (3) of Article 15), the principal employer must, pursuant to Order of the Ministry of Health, Labour and Welfare, appoint an office safety and health manager from among persons holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare, for each workplace at which it has entered into a contract for work in association with the jobs being done at that site in order to prevent industrial injuries from occurring as a result of the work of those persons engaged in work being carried out at the same site, and have that person give guidance to the person who is in charge of the things referred to in the items of paragraph (1) of Article 30 and undertake the other things that are specified by Order of the Ministry of Health, Labour and Welfare at the site where the job associated with the contract for work it has entered into at that workplace is done.

②In a case as referred to in paragraph (4) of Article 30, when the number of all the persons engaged in work as referred to in that paragraph is the number specified by Order of the Ministry of Health, Labour and Welfare or more (excluding when a general safety and health supervisor must be appointed pursuant to the provisions of paragraph (1) or (3) of Article 15), the designated employer that carries out a job involved in an undertaking categorized as the construction industry must, pursuant to Order of the Ministry of Health, Labour and Welfare, appoint an office safety and health manager from among persons holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare, for each workplace at which it has entered into a contract for work in association with the jobs being done at that site, with regard to those persons engaged in work, in order to prevent industrial injuries from occurring as a result of the work of those persons engaged in work being carried out at the same site, and have that person give guidance to the person who is in charge of the things referred to in the items of paragraph (1) of Article 30 and undertake the other things that are specified by Order of the Ministry of Health, Labour and Welfare at the site where the job associated with the contract for work it has entered into at that workplace is done. In such a case, the provisions of the preceding paragraph do not apply to the designated employer or any other employer.

①In a case as referred to in paragraph (1) or (3) of Article 15, a contractor that does not constitute an employer required to appoint a general safety and health supervisor pursuant to those provisions and that carries out the relevant job itself must appoint a safety and health supervisor and have that person communicate with the general safety and health supervisor and undertake the other things that are specified by Order of the Ministry of Health, Labour and Welfare.

②A contractor that has appointed a safety and health supervisor pursuant to the provisions of the preceding paragraph must inform the employer referred to in that paragraph of this without delay.

①At each workplace of the business type and scale specified by Cabinet Order, an employer must establish a safety committee in order to have it investigate and deliberate on the following particulars and submit its opinion to the employer:

②A safety committee is composed of the following persons; provided, however, that only one of the committee members constitutes a person as referred to in item (i) (hereinafter referred to as the "item (i) member"):

③The item (i) member is to be the chairperson of the safety committee.

④An employer must designate persons based on the recommendation of a trade union organized by a majority of workers at the relevant workplace, if any, or by a person representing a majority of workers, if there is no such trade union, to constitute half of the committee members other than the item (i) member.

⑤The provisions of the preceding two paragraphs do not apply to the extent of any separate provisions in a collective agreement concluded with a trade union organized by a majority of the workers at the relevant workplace.

①At each workplace of the scale specified by Cabinet Order, an employer must establish a health committee in order to have it investigate and deliberate on the following particulars and state its opinion to the employer:

②A health committee is composed of the following persons; provided, however, that only one of the committee members constitutes a person as referred to in item (i):

③An employer may designate a worker at the relevant workplace who is an expert in work environment monitoring and is implementing the work environment monitoring, as a member of the health committee.

④The provisions of paragraphs (3) through (5) of the preceding Article apply mutatis mutandis to the health committee. In such a case, the phrase "item (i) member" in paragraphs (3) and (4) of that Article is deemed to be replaced with "a member who is a person as referred to in item (i) of paragraph (2) of Article 18".

①If an employer is required to establish a safety committee and a health committee pursuant to the provisions of Article 17 and the preceding Article, it may set in place a safety and health committee instead of setting in place each of those separate committees.

②A safety and health committee is composed of the following persons; provided, however, that only one of the committee members constitutes a person as referred to in item (i):

③An employer may designate a worker at the relevant workplace who is an expert in work environment monitoring and is implementing the measurement of the work environment, as a member of the safety and health committee.

④The provisions of paragraphs (3) through (5) of Article 17 apply mutatis mutandis to the safety and health committee. In such a case, the phrase "item (i) member" in paragraphs (3) and (4) of that Article is deemed to be replaced with "a member who is a person mentioned in item (i) of paragraph (2) of Article 19".

①In order to increase the level of safety and health in the workplace, an employer must endeavor to provide education and training or the chance of receiving education and training to safety managers, health managers, safety and health advocates, health advocates, and persons engaged in other operations for preventing industrial injuries, in order to improve these person's competencies relevant to the operations in which they are engaged.

②The Minister of Health, Labour and Welfare is to release the necessary guidelines to ensure the appropriate and effective implementation of the education and training referred to in the preceding paragraph.

③The Minister of Health, Labour and Welfare may provide the necessary guidance to employers and associations thereof in accordance with the guidelines referred to in the preceding paragraph.

The State is to endeavor to provide consultations, information, and other necessary support concerning worker healthcare and related duties in order to contribute to ensuring the health of workers at the workplace as provided in paragraph (1) of Article 13-2.

An employer must take the necessary measures to prevent the following dangers:

①An employer must take the necessary measures to prevent dangers arising from work methods involved in operations such as excavation, quarrying, cargo handling, or logging.

②An employer must take the necessary measures to prevent dangers related to places from which workers could fall or when there are concerns about landslides.

An employer must take the necessary measures to prevent the following health impairments:

As regards the constructions and other workspaces where workers are engaged in work, an employer must take the necessary measures for the maintenance of passages, floor and stair areas and the necessary measures for ventilation, lighting, illumination, heating, damp-proofing, rest, evacuation and sanitation, or other measures required to maintain the health, moral, order and lives of workers.

An employer must take the necessary measures to prevent industrial injuries from arising out of the work activities of workers.

If there is an imminent danger of an industrial injury occurring, an employer must immediately stop operations and take the necessary measures to have the workers evacuate from the workspace.

①An employer that carries out a job as specified by Cabinet Order involved in a business undertaking categorized as the construction industry or in any other industry specified by Cabinet Order must take the following measures in order to prevent an industrial injury from occurring in the event that measures for rescuing and protecting persons engaged in work are taken in association with the occurrence of something such as an explosion or fire:

②Pursuant to Order of the Ministry of Health, Labour and Welfare, an employer as prescribed in the preceding paragraph must appoint a person to manage technical issues from among persons holding the qualifications specified by Order of the Ministry of Health, Labour and Welfare, and have that person manage the technical issues that are among the measures referred to in that paragraph.

Workers, and persons engaged in work, other than workers, who are engaged in work on a job at the same site as workers, must observe the necessary rules in response to the measures taken under the provisions of Articles 20 through 25 and of paragraph (1) of the preceding Article that the employer takes.

①The measures required to be taken by the employer pursuant to the provisions of Articles 20 through 25 and of paragraph (1) of Article 25-2, and the measures required to be observed by workers, and by persons engaged in work, other than workers, who are engaged in work on a job at the same site as workers, pursuant to the provisions of the preceding Article are prescribed by Order of the Ministry of Health, Labour and Welfare.

②Consideration must be given, in preparing the Order of the Ministry of Health, Labour and Welfare referred to in the preceding paragraph, so as not to run counter to the purport of laws and regulations concerning the prevention of environmental pollution (meaning environmental pollution defined in paragraph (3) of Article 2 of the Basic Act for Environmental Pollution Control (Act No. 91 of 1993)) and other disasters involving the general public that are closely related to industrial injuries.

①The Minister of Health, Labour and Welfare is to release the necessary technical guidelines for each industry and work operation to ensure the appropriate and effective implementation of the measures that the employer is required to take pursuant to the provisions of Articles 20 through 25 and of paragraph (1) of Article 25-2.

②The Minister of Health, Labour and Welfare is to make special considerations for middle-aged and elderly workers in preparing the technical guidelines specified in the preceding paragraph.

③The Minister of Health, Labour and Welfare is to release guidelines to enable employers that manufacture or handle the chemical substances as follows that are prescribed by the Minister of Health, Labour and Welfare to prevent the impairment of workers' health by those chemical substances:

④Having released technical guidelines or guidelines for preventing the impairment of workers' health pursuant to the provisions of the paragraph (1) or 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 technical guidelines or guidelines for preventing the impairment of workers' health to employers and associations thereof.

①An employer, pursuant to Order of the Ministry of Health, Labour and Welfare, must endeavor to assess things such as the potential for danger or harm from things such as constructions, equipment, raw materials, gases, vapor, and dust,and from work activities and other duties (excluding the things such as the potential for danger or harm due to substances specified by Cabinet Order pursuant to paragraph (1) of Article 57 and substance subject to notice prescribed in paragraph (1) of Article 57-2), and to take the necessary measures to prevent the endangerment of workers or the impairment of workers' health, in addition to taking the measures under the provisions of this Act or an order under this Act, based on the results of those investigations; provided, however, that for those of such investigations that are unrelated to chemical substances, preparations containing chemical substances, and other things that could endanger a worker or impair a worker's health, this is limited to an employer that is in the manufacturing industry or any other industry specified by Order of the Ministry of Health, Labour and Welfare.

②The Minister of Health, Labour and Welfare is to release the necessary guidelines in connection with the measures in the preceding paragraph in order to ensure their appropriate and effective implementation, beyond what is provided for in paragraphs (1) and (3) of the preceding Article.

③The Minister of Health, Labour and Welfare may provide the necessary guidance and assistance to employers and associations thereof in accordance with the guidelines referred to in the preceding paragraph.

①A principal employer must give the necessary guidance so that related contractors and the persons engaged in work associated with related contractors do not contravene the provisions of this Act or an order under this Act in connection with the relevant job.

②On finding that a related contractor or a person engaged in work associated with a related contractor has violated the provisions of this Act or an order based on this Act in connection with the relevant job, the principal employer must give the instructions necessary to rectify this.

③A related contractor or a person engaged in work associated with a related contractor that has been given instructions as referred to in the preceding paragraph must abide by those instructions.

A principal employer with a business undertaking categorized as the construction industry must, when persons engaged in work associated with a related contractor are doing work on a job involved in that undertaking at a site specified by Order of the Ministry of Health, Labour and Welfare, such as a site where there is a risk of soil collapse, etc., or a site where there is a risk of machinery or other such equipment overturning, give technical guidance and take other necessary measures to ensure that the measures that the related contractor is to take in order to prevent dangers associated with that site are being taken appropriately.

①In order to prevent industrial injuries from occurring as a result of work being carried out at the same site by the persons engaged in work who are workers of the specified principal employer (including, if there are persons engaged in work associated with that specified principal employer who are not workers in addition to the persons engaged in work who are its workers, those persons) and the persons engaged in work associated with related contractors, a specified principal employer must take the necessary measures concerning the following things:

②If an original orderer (meaning an orderer that places an order without having been contracted for that job by any other person; the same applies hereinafter) of a job involved in a specified undertaking, other than a specified principal employer, has contracted out, to two or more contractors, a job involved in a specified undertaking which is being carried out at a single site, and the persons engaged in work (limited to workers and to persons engaged in work, other than workers, who are engaged in work on a job at the same site as workers) associated with the two or more contractors involved in that job will work at that site, that original orderer, pursuant to Order of the Ministry of Health, Labour and Welfare, must designate one person from among those of the contractors that constitute employers carrying out that job themselves, as the person that is to take the measures prescribed in the preceding paragraph. The same applies to a person that has been contracted to undertake all of the jobs involved in a specified undertaking being carried out at a single site, other than a specified principal employer, and that has contracted out those jobs to two or more contractors.

③If a designation under the provisions of the preceding paragraph is not made, the Chief of the Labour Standard Inspection Offices makes the designation referred to in that paragraph.

④When a designation under the provisions of paragraph (2) or the preceding paragraph has been made, the designated employer must take the measures provided for in paragraph (1) for all persons engaged in work on the jobs at that site. In such a case, the provisions of that paragraph do not apply to the designated employer and employers other than the designated employer.

①The principal employer with a business undertaking (excluding specified undertakings) categorized as the manufacturing industry or in any other industry specified by Cabinet Order must take measures for liaison and coordination between related work and other necessary measures, in order to prevent industrial injuries from occurring as a result of work being carried out at the same site by the persons engaged in work who are its workers (including, if there are persons engaged in work associated with the principal employer who are not workers in addition to the persons engaged in work who are its workers, those persons) and the persons engaged in work associated with related contractors.

②The provisions of paragraph (2) of the preceding Article apply mutatis mutandis to the original orderer of a job involved in a business undertaking prescribed in the preceding paragraph. In this case, the term "the specified principal employer", "a job involved in a specified undertaking", "in the preceding paragraph", and "all of the jobs involved in a specified undertaking", each in paragraph (2) of that Article, are deemed to be replaced with "the principal employer", "a job", "paragraph (1) of the following Article", and "all jobs", respectively.

③If a designation under the provisions of paragraph (2) of the preceding Article as applied mutatis mutandis pursuant to the preceding paragraph is not made, the Chief of the Labour Standard Inspection Offices makes the designation referred to in that paragraph.

④When a designation under the provisions of paragraph (2) of the preceding Article as applied mutatis mutandis pursuant to paragraph (2), or under the provisions of the preceding paragraph has been made, the designated employer must take the measures specified in paragraph (1) for all persons engaged in work on the jobs at that site. In such a case, the provisions of that paragraph do not apply to the designated employer and employers other than that designated employer.

①If a job as prescribed in paragraph (1) of Article 25-2 is carried out based on multiple levels of contracts (other than in a case as referred to in paragraph (4)), the principal employer must take the measures set forth in each item of paragraph (1) of that Article for all persons engaged in work on that job at the relevant site; in this case, the provisions of that paragraph do not apply to the principal employer and employers other than the principal employer.

②The provisions of paragraph (2) of the Article 30 apply mutatis mutandis to the original orderer of a job prescribed in paragraph (1) of Article 25-2. In such a case, the phrases "the specified principal employer", "a job involved in a specified undertaking", "the measures provided for in the preceding paragraph", and "all of the jobs involved in a specified undertaking", each in paragraph (2) of the Article 30, are deemed to be replaced with "the principal employer", "a job", "the measures provided for in each item of paragraph (1) of Article 25-2", and "all of the jobs", respectively.

③If a designation under the provisions of paragraph (2) of Article 30 as applied mutatis mutandis pursuant to the preceding paragraph is not made, the Chief of the Labour Standard Inspection Offices makes the designation referred to in that paragraph.

④When a designation under the provisions of paragraph (2) of Article 30 as applied mutatis mutandis pursuant to paragraph (2) or under the preceding paragraph is made, the designated employer must take the measures set forth in the items of paragraph (1) of Article 25-2 for all persons engaged in work on the jobs at that site; in such a case, the provisions of that paragraph do not apply to the designated employer and employers other than the designated employer.

⑤The provisions of paragraph (2) of Article 25-2 apply mutatis mutandis to the principal employer prescribed by paragraph (1) and to the designated employer referred to in the preceding paragraph. In such a case, the provisions of paragraph (2) of that Article do not apply to the principal employer and the designated employer, and employers other than those employers.

①An orderer that directly carries out a job involved in a specified undertaking must, when having persons engaged in work (limited to workers and to persons engaged in work, other than workers, who are engaged in work on a job at the same site as workers) associated with the contractor of this orderer (including the parties to all contracts for work subsequent to the one with that contractor, if the job is carried out based on multiple levels of contracts) use a construction, equipment, or raw material (hereinafter referred to as the "construction, equipment, or raw material") at the site where it carries out that job, take the necessary measures in respect of the relevant construction, equipment, or raw material to prevent industrial injuries.

②If there are two or more orderers required to take the measures under the preceding paragraph in respect of the same construction, equipment, or raw material, owing to the jobs involved in the relevant undertaking being carried out based on multiple levels of contracts, the provisions of the preceding paragraph do not apply to the orderers of the subsequent contracts.

The orderer of work a job involving for works specified by Order of the Ministry of Health, Labour and Welfare, such as the alteration of equipment that is used to facilities for the manufactureing or handle aing of substance such as chemical substances, or a preparations containing a chemicals substance, or any other material, and that is specified by Cabinet Order, or of a job involving any other work as specified by Ordinance of Ministry of Health, Labour and Welfare, must take the necessary measures, concerning in respect of that substance, or materialsubstances to prevent workers of contractors of the work froman industrial accident among the workers of contractors involved in the relevant jobs.

①When persons engaged in work (limited to workers and to persons engaged in work, other than workers, who are engaged in work on a job at the same site as workers) associated with two or more employers or individual business operators (meaning persons conducting a business who do not employ workers; the same applies hereinafter) who are carrying out jobs involved in business undertakings categorized as the construction industry are doing work at one site involving machinery which is specified by Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as "specified work" in this Article), an original orderer that directly carries out a job associated with the specified work or a person that has been contracted for all of that job, that contracts out a part of the job at that site must take the necessary measures to prevent industrial injuries among all of the workers engaged in the specified work at that site pursuant to Order of the Ministry of Health, Labour and Welfare.

②In a case as referred to in the preceding paragraph, if there is no person that, pursuant to the provisions of that paragraph, is required to take the measures prescribed in that paragraph, the principal employer with a business undertaking categorized as the construction industry that has contracted out all of the jobs associated with specified operation at that site to contractors or the employer specified pursuant to the provisions of paragraph (2) or (3) of Article 30 that is carrying out an undertaking categorized as the construction industry must give the necessary consideration for preventing industrial accidents among all of the workers who are engaged in the specified operation at the site, such as nominating a person to carry out the measures designated in the preceding paragraph.

An orderer must not give its contractor (including the parties to all contracts for work subsequent to the one with that contractor, if a job is carried out based on multiple levels of contracts) an instruction in connection with the relevant job that would result in a violation of the provisions of this Act or an order issued under this Act if the persons engaged in work associated with that contractor did work in accordance with the instruction.

①In a case as referred to in paragraph (1) or (4) of Article 30, a contractor that does not constitute an employer obliged to take the measures provided for in paragraph (1) of that Article, and that directly carries out the relevant job must take the necessary measures based on the measures that are taken pursuant to those provisions.

②In a case as referred to in paragraph (1) or (4) of Article 30-2, a contractor that does not constitute an employer obliged to take measures provided for in paragraph (1) of that Article, and that directly carries out the job must take the necessary measures, based on the measures that are taken pursuant to those provisions.

③In a case as referred to in paragraph (1) or (4) of Article 30-3, a contractor that does not constitute an employer obliged to take measures in each item of paragraph (1) of Article 25-2, and that directly carries out the job must take the necessary measures, based on the measures that are taken pursuant to the provisions of paragraph (1) or (4) of Article 30-3.

④In a case as referred to in paragraph (1) of Article 31, a contractor associated with the persons engaged in work who are using the relevant construction, equipment, or raw material must take the necessary measures, based on the measures that are taken pursuant to the provisions of that paragraph.

⑤In a case as referred to in Article 31-2, a contractor involved in a job as provided for in this Article must take the necessary measures, based on the measures taken pursuant to the provisions of that Article.

⑥In a case as referred to in paragraph (1) or (4) of Article 30, paragraph (1) or (4) of Article 30-2, paragraph (1) or (4) of Article 30-3, paragraph (1) of Article 31, or Article 31-2, persons engaged in work must observe the necessary rules in accordance with the measures taken pursuant to these provisions or the provisions of each of the preceding paragraphs.

⑦A contractor as referred to in paragraphs (1) through (5) and a person engaged in work as referred to in the preceding paragraph must follow the instructions given by the specified principal employer, etc. referred to in paragraph (1) of Article 30, the principal employer, etc. referred to in paragraph (1) of Article 30-2 or paragraph (1) of Article 30-3, the orderer referred to in paragraph (1) of Article 31 or Article 31-2, or the contractor referred to in paragraphs (1) through (5), for ensuring the implementation of the measures under the provisions of paragraph (1) or (4) of Article 30, paragraph (1) or (4) of Article 30-2, paragraph (1) or (4) of Article 30-3, paragraph (1) of Article 31, Article 31-2, or paragraphs (1) through (5).

①A person that leases out the machinery or other such equipment that is specified by Cabinet Order to a person conducting a business, and that is specified by Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as a "lessor of machinery or other such equipment") must take the necessary measures to prevent industrial injuries due to leased machinery or other such equipment at the workplace of the person conducting a business that rents that machinery or other such equipment.

②A person that rents machinery or other such equipment from a lessor of machinery or other such equipment must take the necessary measures to prevent industrial injuries due to the operation of the machinery or other such equipment, if the operator of the machinery or other such equipment is not a worker employed thereby.

③A worker that operates machinery or other such equipment as referred to in the preceding paragraph must observe the necessary rules in accordance with the measures that the person renting the machinery or other such equipment takes pursuant to the provisions of that paragraph.

A person that leases out a building that is as specified by Cabinet Order to persons conducting a business (hereinafter referred to as a "building lessor") must take the necessary measures to prevent industrial injuries due to the leased building in relation to the business of the persons renting it; provided, however, that this does not apply if all of the building is leased out to one employer or individual business operator, or if it is leased out only to two or more individual business operators.

A person seeking to forward a piece of cargo which weighs one ton or more must label the cargo with its weight in a way that is easy to see and not easily erasable; provided, however, that this does not apply if a person is forwarding unpackaged cargo the weight of which is clear at a glance.

The measures to be taken pursuant to the provisions of paragraph (1) or (4) of Article 30, paragraph (1) or (4) of Article 30-2, paragraph (1) or (4) of Article 30-3, paragraph (1) of Article 31, Article 31-2, paragraphs (1) through (5) of Article 32, paragraph (1) or (2) of Article 33, or Article 34, by the parties mentioned in these provisions, and the matters to be observed pursuant to the provisions of paragraph (6) of Article 32 or paragraph (3) of Article 33 by the parties mentioned in these provisions are prescribed by Order of the Ministry of Health, Labour and Welfare.

①A person seeking to manufacture machinery or other such equipment that is set forth in Appended Table 1 as necessitating particularly dangerous work operations, and also specified by Cabinet Order (hereinafter referred to as "specified machinery or other such equipment"), must obtain permission from the Director of the Prefectural Labour Bureau in advance, pursuant to Order of the Ministry of Health, Labour and Welfare.

②When a person has applied for the permission referred to in the preceding paragraph, the Director of the Prefectural Labour Bureau examines the application, and must not give the permission referred to in that paragraph unless the director finds that the construction of the specified machinery or other such equipment to which the application pertains complies with the standards provided for by the Minister of Health, Labour and Welfare.

③An application for the permission referred to in paragraph (1) must be made, pursuant to Order of the Ministry of Health, Labour and Welfare, with a document attached that states the results of a review (hereinafter referred to as a "design review") conducted by a person registered by the Minister of Health, Labour and Welfare for each type of specified machinery or other such equipment pertaining to the machinery or other such equipment set forth in Appended Table 1 (hereinafter referred to as a "registered agency for design reviews and post-manufacturing inspections") as to whether the design of the specified machinery or other such equipment to which the application pertains conforms to the part of the standards referred to in the preceding paragraph that relates to the construction of specified machinery or other such equipment; provided, however, that this does not apply when the Director of the Prefectural Labour Bureau carries out the operations for design reviews of the specified machinery or other such equipment to which the application pertains pursuant to the provisions of paragraph (1) of Article 53-2.

①Pursuant to Order of the Ministry of Health, Labour and Welfare, a person that has manufactured or imported specified machinery or other such equipment (limited to that pertaining to the machinery or other such equipment set forth in items (i), (ii), (iv) and (viii) of Appended Table 1; the same applies in this paragraph, the following paragraph and paragraph (1) of the following Article), a person seeking to install specified machinery or other such equipment which has not been installed for the period specified by Order of the Ministry of Health, Labour and Welfare, or a person seeking to reinstall or resume the use of specified machinery or other such equipment whose use has been discontinued must undergo an inspection by a registered agency for design reviews and post-manufacturing inspections with respect to that specified machinery or other such equipment itself and the related particulars that are prescribed by Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply if, for specified machinery or other such equipment that has been imported and the particulars related to it that are specified by Order of the Ministry of Health, Labour and Welfare (referred to as "machinery or other such equipment subject to import inspection" in the following paragraph), the person that manufactured the specified machinery or other such equipment in a foreign country has undergone an inspection under the provisions of that paragraph.

②Beyond as provided in the preceding paragraph, in a case set forth in one of the following items, pursuant to Order of the Ministry of Health, Labour and Welfare, a person that has manufactured specified machinery or other such equipment in a foreign country may itself undergo an inspection by a registered agency for design reviews and post-manufacturing inspections for machinery or other such equipment subject to import inspection:

③A person that has installed specified machinery or other such equipment (excluding anything that is movable), a person that has changed any parts provided for by Order of the Ministry of Health, Labour and Welfare of specified machinery or other such equipment, or a person that seeks to resume the use of specified machinery or other such equipment whose use has been discontinued, must undergo an inspection by the Chief of the Labour Standard Inspection Offices in respect of the specified machinery or other such equipment and the related particulars that are prescribed by Order of the Ministry of Health, Labour and Welfare, pursuant to Order of the Ministry of Health, Labour and Welfare.

①Pursuant to Order of the Ministry of Health, Labour and Welfare, a registered agency for design reviews and post-manufacturing inspections issues an inspection certificate for movable specified machinery or other such equipment that has passed an inspection as referred to in paragraph (1) or (2) of the preceding Article (hereinafter referred to as a "post-manufacturing inspection").

②Pursuant to Order of the Ministry of Health, Labour and Welfare, the Chief of the Labour Standard Inspection Offices issues an inspection certificate for specified machinery or other such equipment that has passed the inspection referred to in paragraph (3) of the preceding Article in connection with the installation of specified machinery or other such equipment.

③Pursuant to Order of the Ministry of Health, Labour and Welfare, the Chief of the Labour Standard Inspection Offices endorses the inspection certificate of specified machinery or other such equipment that has passed an inspection as referred to in paragraph (3) of the preceding Article in connection with the partial alteration or resumption of the use of specified machinery or other such equipment.

①A person must not use specified machinery or other such equipment for which an inspection certificate provided for in paragraph (1) or (2) of the preceding Article (hereinafter referred to as an "inspection certificate") has not been issued (including specified machinery or other such equipment that must be inspected in connection with a partial alteration or resumption of use pursuant to the provisions of paragraph (3) of Article 38, but for which the inspection certificate has not been endorsed as provided for in paragraph (3) of the preceding Article).

②Specified machinery or other such equipment for which an inspection certificate has been issued must neither be transferred nor leased out unless accompanied by that certificate.

①The valid term of an inspection certificate (or, if the valid term of an inspection certificate is renewed pursuant to the provisions of the following paragraph, the valid term of the inspection certificate as renewed) is the period specified by Order of the Ministry of Health, Labour and Welfare in line with that kind of specified machinery or other such equipment.

②Pursuant to Order of the Ministry of Health, Labour and Welfare, a person seeking to renew the valid term of an inspection certificate must undergo a performance inspection by a person registered by the Minister of Health, Labour and Welfare (hereinafter referred to as a "registered agency for performance inspections") in respect of the specified machinery or other such equipment and the related particulars that are prescribed by Order of the Ministry of Health, Labour and Welfare.

Machinery or other such equipment that does not constitute specified machinery or other such equipment, but which is set forth in Appended Table 2 or otherwise necessitates dangerous or hazardous work operations, is used in a dangerous place, or is used to prevent the endangerment of a person or impairment of a person's health, and that is specified by Cabinet Order must not be transferred, leased out, or installed unless they fulfill the standards or safety device equipment requirements established by the Minister of Health, Labour and Welfare.

Power-driven machinery or other such equipment without protective measures specified by Order of the Ministry of Health, Labour and Welfare on projecting parts of its moving parts, power transmission sections, or speed regulatory sections must neither be transferred nor be leased out, and must not be exhibited with a view to transferring it or leasing it out.

If a person that has manufactured or imported machinery or other such equipment as referred to in in Article 42 has transferred or leased out machinery or other such equipment so manufactured or imported that falls under one of the following items, the Minister of Health, Labour and Welfare or the Director of the Prefectural Labour Bureau may order that person to recall or improve the machinery or other such equipment, to provide the information specified by Order of the Ministry of Health, Labour and Welfare to persons using that machinery or other such equipment, or to otherwise take necessary measures to prevent an industrial injury due to the machinery's or other such equipment's being used:

①Pursuant to Order of the Ministry of Health, Labour and Welfare, a person that manufactures or imports machinery or other such equipment as referred to in Article 42 (excluding machinery or other such equipment prescribed in paragraph (1) of the following Article) which is set forth in Appended Table 3 and specified by Cabinet Order must subject itself to examinations for that machinery or other such equipment that an agency registered by the Minister of Health, Labour and Welfare (hereinafter referred to as a "registered agency for individual examinations") undertakes on an individual basis.

②Notwithstanding the provisions of the preceding paragraph, if the person that has imported the machinery or other such equipment referred to in the preceding paragraph is a person other than the person manufacturing it in a foreign country (hereinafter referred to as a "foreign manufacturer" in this paragraph; a person other than the foreign manufacturer is referred to simply as "other persons" hereinafter in this paragraph), and the foreign manufacturer does not wish to have examinations as referred to in the preceding paragraph undertaken in respect of other persons, the foreign manufacturer, pursuant to Order of the Ministry of Health, Labour and Welfare, may itself undergo examinations for that machinery or other such equipment that a registered agency for individual examinations undertakes on an individual basis. Those provisions do not apply to a person importing machinery or other such equipment if the above individual examinations have been made.

③Having received an application from a person seeking to undergo an examination as referred to in the preceding two paragraphs (hereinafter referred to as an "individual examination"), a registered agency for individual examinations must not give a passing result on the individual examination unless the machinery or other such equipment to which the application pertains is found to conform to the standards set by Order of the Ministry of Health, Labour and Welfare.

④A person that has undergone individual examinations, pursuant to Order of the Ministry of Health, Labour and Welfare, must affix a label to the machinery or other such equipment that has passed the individual examination indicating it to have passed that individual examination.

⑤It is prohibited to affix a label as referred to in the preceding paragraph or a label misleadingly similar thereto to machinery or other such equipment other than that which has passed an individual examination.

⑥A person must not use machinery or other such equipment as referred to in paragraph (1) that does not have a label as referred to in paragraph (4) affixed to it.

①Pursuant to Order of the Ministry of Health, Labour and Welfare, a person that has manufactured or imported machinery or other such equipment as referred to in Article 42 which is set forth in Appended Table 4 and specified by Cabinet Order must undergo an examination regarding that machinery's or other equipment's type that a person registered by the Minister of Health, Labour and Welfare (hereinafter referred to as a "registered agency for type examinations") undertakes; provided, however, that this does not apply to any such machinery or other such equipment that has been imported and for which an examination as referred to in the following paragraph has been undertaken.

②Beyond as prescribed in the preceding paragraph, in the following cases, pursuant to Order of the Ministry of Health, Labour and Welfare, a person that has manufactured machinery or other such equipment referred to in the first part of the preceding paragraph in a foreign country (hereinafter referred to as a "foreign manufacturer" in this paragraph and Article 44-4) may itself undergo an examination regarding that machinery's or other such equipment's type that a registered agency for type examinations undertakes:

③Having received an application from a person seeking to undergo an examination as referred to in the preceding two paragraphs (hereinafter referred to as a "type examination"), a registered agency for type examinations must not give a passing result on the type examination unless it finds that the construction of the machinery or other such equipment and the equipment used for manufacturing and inspecting that machinery or other such equipment conforms to the standards specified by Order of the Ministry of Health, Labour and Welfare.

④A registered agency for type examinations issues an applicant a type examination certificate for the type for which it has passed the type examination.

⑤When a person that has undergone a type examination has manufactured in Japan or imported into Japan machinery or other such equipment of a type for which it has passed a type examination, that person, pursuant to Order of the Ministry of Health, Labour and Welfare, must affix a label indicating that it constitutes machinery or other such equipment of a type for which it has passed a type examination. The same applies to a person that has imported into Japan machinery or other such equipment of a type for which a type examination has been passed (but only one that is not itself the person that has undergone that type examination).

⑥It is prohibited to affix a label as referred to in the preceding paragraph or a label misleadingly similar thereto to machinery or other such equipment other than that for which a person has passed a type examination.

⑦A person must not use machinery or other such equipment as referred to in the main clause of paragraph (1) that does not have a label as referred to in paragraph (5) affixed to it.

①The 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.

②A 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.

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)):

①An 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.

②If 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").

③Specified inspections must be conducted in accordance with the standards specified by the Minister of Health, Labour and Welfare.

④The 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).

⑤Having 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.

①The 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").

②A person falling under any of the following items may not be registered:

③The 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:

④The 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:

①If 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..

②The provisions of paragraphs (2) through (4) apply mutatis mutandis to the renewal of a registration referred to in the preceding paragraph.

①If 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.

②A 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.

③A 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.

④When 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.

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.

①A 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.

②The 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.

①Within 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.

②A 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:

③If 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:

④A 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.