This webpage contains information on notifications on the self-inspection of in vitro diagnostics issued by the Ministry of Health, Labour and Welfare (MHLW). The marketing authorization holders perform a self-inspection in accordance with the notice, and, as a result, they will revise the package inserts or user manuals.
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Regulations & Services of PMDAInformation about Approved Products in JapanSafety InformationAdvanced Efforts
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Information for approved products in JapanSafety information
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnosticsInformation for approved products in JapanRegulatory science
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Regulations and services of PMDAInformation for approved products in JapanProcedures in JapanAdvanced efforts
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Regulations and Services of PMDAInformation for apporoved products in JapanSafety informationProcedures in Japan
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Regulations and Services of PMDAInformation for apporoved products in JapanSafety informationProcedures in Japan
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Reviews and Related ServicesRegulatory ProceduresPost-marketing Safety Measures
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Reviews and Related ServicesPost-marketing Safety Measures
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- Post-marketing Safety Measures
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- Notification on Self-inspection
Post-marketing Safety Measures