Japan Medical Device

Showing 1–16 of 19 results

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  Guidance for Eval of (AI) Assisted Systems

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

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  March 26, 2025 Office of New Drug II Pharmaceuticals and Medical Devices Agency

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  Marketing Application – Home use MD for Diagnostic

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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.2 Regulations for Facilities of Pharmacies in Japan

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  Ministerial Ordinance on Good Clinical Practice for Drugs

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

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  PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics

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  PFSB/ELD Notification No. 0611-1 June 11, 2012 Guideline for Clinical Evaluation of Diagnostic Radiopharmaceuticals

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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 Guidelines: Clinical Study Data on Medical Devices from Foreign Clinical Studies 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: New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law

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  PMDA: Points to Consider for Reprocessed Single-use Medical Devices

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