Pursuant 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.
Notwithstanding 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.
Having 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.
A 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.
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 which has passed an individual examination.
A 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.
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