A person who intends to market a medical device or in-vitro diagnostic reagent which is designated by the Minister of Health, Labour and Welfare shall be granted a certification by a person who has been registered by the Minister (hereinafter referred to as "Registered Certification Body"). PMDA performs assessments to the Registered Certification Bodies (and persons who intend to be Registered Certification Bodies) to confirm if they are complied to the criteria for the registration.
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