JAPAN Law and Practice Contributed by: Junichi Ikeda, Takayuki Fujii, Satoyuki Nakano and Tomoaki Kitaguchi, Nagashima Ohno & Tsunematsu
ing them, without affixing the PSC mark under the CPSA. Certain specific products are exclusively regulat - ed by other regulators. For example, the Ministry of Land, Infrastructure, Transport and Tourism (MLIT) regulates automobiles; and the Ministry of Health, Labour and Welfare (MHLW) regulates medical products, cosmetics and medical devic - es, as well as food, food additives and clean - ing agents. These regulators have the power to establish technical or other relevant standards. If certain conditions are met, these regulators can order the manufacturer to implement reme - dial measures, including the implementation of product recalls. 1.3 Obligations to Commence Corrective Action General The Basic Consumer Act provides that the Japanese government must take the necessary measures to ensure the safety of consumers, such as: • requiring business operators to recall goods that may be detrimental to safety; and • collecting and providing information on goods and services that may be detrimental to safety. Business operators are expected to implement a product recall if a product that they manufacture, import or sell might be detrimental to the safety of its consumers. Under the CPSA, any person engaged in the manufacture or import of consumer products must investigate the cause of any product inci - dents that occur involving such products. The manufacturer or importer must endeavour to either recall the products or take measures to
improve their safety and prevent the occurrence of further product incidents. Sector-Specific Medical Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceu - ticals and Medical Devices, holders of a mar - keting authorisation for pharmaceuticals, quasi- pharmaceutical products, cosmetics, medical devices or regenerative medicine products, or persons with special approval regarding the foreign manufacturing of these products, must, when they learn of the occurrence or spread of hazards in health and hygiene suspected to be caused by using such products that they have manufactured and sold – or for which they have received certain approval – dispose of, recall, discontinue selling and provide information on such products, and take other necessary meas - ures for the prevention of the occurrence or spread of hazards to health and hygiene. Automotive Under the Road Trucking Vehicle Act (including a guideline established thereunder), in cases where the structure, mechanism or perfor - mance of a certain range of automobiles of the same model does not, or is not likely to, con - form with the necessary safety standards, and the cause relates to the design or manufacture of the automobiles, a manufacturer or importer must promptly recall the automobiles and report certain matters specified in the Act to the MLIT. Food standards Under the FSA, a food business operator must endeavour to take all necessary measures, appropriately and immediately, to prevent food sanitation hazards resulting from the sale of food, etc, such as the provision of a certain record to the relevant state or prefectures and
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