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Japan
PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software
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Japan
PSEHB No. 0731-1 : Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)
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Japan
PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics
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Japan
Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices
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Japan
Ministerial Ordinance on Good Clinical Practice for Drugs
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Japan
PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs
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