Pursuant 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.
Beyond 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:
if the person seeks to export the machinery or other such equipment to Japan;
当該機械等を本邦に輸出しようとするとき。
if the person that has imported the machinery or other such equipment is a person other than the foreign manufacturer (hereinafter such persons are referred to simply as "other persons"), and the foreign manufacturer does not wish to have examinations as referred to in the preceding paragraph undertaken for other persons.
Having 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.
A registered agency for type examinations issues an applicant a type examination certificate for the type for which it has passed the type examination.
When 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).
It 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.
A 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.
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