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
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
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;
損害保険契約の契約内容を記載した書類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
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
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.
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