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Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
    Quality regulations
  8. Export & Import
  9. Pricing & Reimburcement
  10. Marketing
  11. Postmarketing
  12. Reevaluation & Reexamination
Medical Devices
Japan Monitor (ISSN 1550-3429)
Information Meetings
Legislation and Agreements
All in Japan (ISSN 1550-3402)
E-health Japan (ISSN 1550-3410)
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Standards for Manufacturing Control and QA for Medical Devices / In-vitro Diagnostics (Single User)

Standards for Manufacturing Control and QA for Medical Devices / In-vitro Diagnostics (Single User)Quantity in Basket:none
Code: 7_D_B005

51-page Medicinal Products Lifecycle document. Single user license. Full text in English of the MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents, MHLW Ordinance No. 169, December 17, 2004 (also known as the “Quality Management Systems Ordinance" or shortly as the “QMS Ordinance". Formatted, indexed, annotated and hyperlinked. Jouhou Koukai Publishing is a Jouhou Koukai business: pharmaceuticals, medical devices, drug approval, regulations, clinical trials, Japan pharmaceutical affairs, and global and Japanese regulatory affairs. Retrieval and consulting on drug approval and technical documents disclosed in Japan. (ISSN 1550-3437) Copyright © JKS LLC 2006.

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