A 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.
The 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.
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