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Focus on Japan Series: Part III – Registering Facilities under Foreign Manufacturer Accreditation (FMA)

Medical device organizations that manufacture products outside of Japan, but plan to market within this geography, are required to obtain accreditation by the Minister of Health, Labour and Welfare (MHLW), or what is referred to as Foreign Manufacturer Accreditation (FMA). A critical step in receiving an FMA includes undergoing proper inspection of manufacturing buildings and … Continued