Article 47Obligation to Conduct Design Reviews or Post-Manufacturing Inspections, etc.

①If requested to conduct a design review or post-manufacturing inspection, a registered agency for design reviews and post-manufacturing inspections must conduct a design review or post-manufacturing inspection without delay unless it has a legitimate reason not to do so.

②A registered agency for design reviews and post-manufacturing inspections must, in conducting design reviews, have these implemented by reviewers, and, in conducting post-manufacturing inspections, have these implemented by inspectors.

③A registered agency for design reviews and post-manufacturing inspections must conduct design reviews or post-manufacturing inspections fairly and in accordance with the part of the standards referred to in paragraph (2) of Article 37 that relates to construction and the methods specified by the Minister of Health, Labour and Welfare.

④When conducting post-manufacturing inspections, a registered agency for design reviews and post-manufacturing inspections must take measures that Order of the Ministry of Health, Labour and Welfare prescribes as the necessary measures to prevent danger from arising from an inspection method in a post-manufacturing inspection.