PMDA

Showing 1–16 of 24 results

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  Japan PMDA: Application for Marketing Authorization for Medical Devices in Japan

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  Japan’s PMDA: C-Reactive Protein Assay Kit Registration Technical Review Guideline

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  MHLW-PFSB No. 0331002 :Timeline for New Drug Applications

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  Ministerial Ordinance 136: Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices

  $75.00 Original price was: $75.00.$60.00Current price is: $60.00. Add to cart
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  Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices

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  Ministerial Ordinance No.21 – Good Laboratory Practice for Nonclinical Safety Studies of Drugs

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  Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices

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  Notification No. 0620-6 – Study Data for New Drug Applications

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  PFSB/ELD Notification No. 0527-1,2010 Vaccines Against the Novel Coronavirus SARS-CoV-2

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  PFSB/ELD Notification No. 1228-7 Basic Principles of Risk-based Monitoring

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  PMDA Guideline: Master File System for Drug Substances (MF) in Japan

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  PMDA Guideline: Application for Accreditation of Foreign Manufacturers (FMA) to PMDA in Japan

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  PMDA Guideline: Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) in Japan

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  PMDA Guideline: Cosmetic Standards in Japan

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  PMDA Guidline: Applications for Marketing Approval related to the Handling of Medical Device Software in Japan

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  PMDA Notification No.171/2004: Procedures for Developing Post-marketing Study Plan

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