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PMDA Pharmaceuticals and Medical Devices Agency, Japan

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Services of PMDA

  • Drug and Medical Device Reviews
  • Outline
  • Approved Products
  • List of Approved Products
  • Review Reports: Drugs
  • Review Reports: Medical Devices
  • Package Inserts (in Japanese)
  • Regulations and Procedures
  • Good Review Practice
  • Projects Across Multi-Offices in PMDA
  • Record of Consultations on Pharmacogenomics/ Biomarkers
  • Post-marketing Safety
  • Outline
  • Safety Information
  • PMDA Risk Communications
  • Safety Information announced by MHLW
  • MHLW Pharmaceuticals and Medical Devices Safety Information
  • PMDA Medical Safety Information
  • PMDA Request for Proper Use of Drugs
  • Other Information (in Japanese)
  • MIHARI project
  • Regulations (in Japanese)
  • Relief Services for Adverse Health Effects
  • Outline

International Programs

About PMDA

Approved Products

Safety Information

Regulations and Procedures

Publications

Past Events/Symposia

Japanese Pharmacopoeia

QMS

Guidance on QMS

  •  Quality Management System Inspection of Medical Devices and in-vitro Diagnostics in Japan

Ministerial Ordinance on QMS

  •  Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (Tentative Translation:as of September 9, 2005) [QMS]

Pharmaceuticals and Medical Devices Agency

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan