• (3) The Minister of Health, Labor and Welfare shall register a person who applied for registration pursuant to the provision of paragraph (1)(referred to as “applicant for registration” in this paragraph), if the applicant satisfies all the following matters:
o (i) The applicant for registration shall conduct the manufacturing inspection, etc.,using machine and apparatus listed in Appended Table 5 and other facilities.
o (ii) The number of persons who conduct the manufacturing inspection, etc. (restricted only to those who have knowledge and experience which meet one of the requirements listed in item
o (i) of Appended Table 6,
hereinafter referred to as “inspector”) shall be equal to or more than the figure shown in item (ii) of the same Table.
o (iii) An inspector who has knowledge and experience which meet one of the requirements listed in Appended Table 7 shall instruct the inspectors and supervise the manufacturing inspection, etc.
o (iv) The applicant for registration as dependent on the manufacturer or the importer of specially specified machines, etc. (hereinafter referred to as “manufacturer, etc.” in this item) shall not fall under any of following items:
(a) In the case that the applicant for registration is a joint-stock company, the manufacturer, etc. is a parent juridical person (referred to as the parent company pursuant to paragraph 1 of Article 879 of Company Act (Act No. 86 of 2005) of the said applicant.
(b) ) The ratio of executive officials (for a partnership company (referred to as the partnership company pursuant to paragraph 1 of Article 575 of the Company Act), company members who execute the company business) or staff of the manufacturer, etc. (including persons who have been executive officials or staff of the said manufacturer, etc. within past two years) to executive officials of the applicant for registration exceeds one half.