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Japan Medical Device Market and Regulatory Report

Published by Japan MDC


"The Japan Medical Device Market and Regulatory Report 2015" comprehensively cover all aspects of pharmaceutical regulations and business for Medical Devices in Japan.
It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development.
It also includes an overview of the Japanese Medical Devices market and overseas involvement in the market.

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"Japan Medical Device Market and Regulatory Report 2015"

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I. Introduction and Summary
Regulatory environment

II. Japan’s Medical Devices Market Environment
II-1. Market opportunities in Japan

III. Japan’s Pharmaceutical Affairs Law (PAL)
III-1. Medical device approval and certification in Japan
III-2.Regenerative Medicine Medical device regulation in Japan
III-2-1. Introduction
III-2-2. Definition of Cellular and Tissue-based Products
III-2-3. Marketing of Cellular and Tissue-Based Products
III-2-4. Conditional Approval of Cellular and Tissue-Based Products
III-2-5. Data Attached to Approval Application (for New Cellular and Tissue-Based Products
III-3.Program Medical Devices

IV. Medical Device Evaluation System in Japan
IV-1. Marketing Authorization Holder system
IV-2. Overseas manufacturer accreditation for medical devices

V. Japanese Classification of Medical Devices
V-1. Specially controlled medical devices (Class III & Class IV)
V-2. Controlled medical devices/designated controlled medical devices (Class II)
V-3. General medical devices (Class I)
V-4. Medical devices requiring specially designated maintenance management

VI. Japan’s Registration Process
VI-1. Registration steps for overseas manufacturers

VII. Requirements for Product Approval (referred to as shonin in Japanese)
VII-1. Procedural flow
VII-2. Application categories for medical devices
VII-3. Approval standards for medical devices
VII-4. Key factors in determining the necessity of clinical trial data
VII-5. Completion of application documents
VII-5-1. Application form
VII-5-2. Technical documents

VIII. Requirements for Certification (referred to as ninsho in Japanese)
VIII-1. Definition of Certification Standards
VIII-2. Flow of certification procedure
VIII-3. Requirements for certification submission
VIII-3-1. Application form
VIII-3-2. Technical documents

IX. Requirements for Notification (referred to as todokede in Japanese)
IX-1. Flow of notification procedure
IX-2. Application documents for notification

X. Medical Device GMP -QMS: Quality Management System-
X-1. Applicable scope
X-2. GMP/QMS as an essential requirement
X-3. GMP/QMS conformity audits

XI. Clinical Trials
XI-1. Japan’s Requirements for Clinical Trials
XI-2. Japan’s Medical Device GCP
XI-2-1. Requirements of principle investigator (PI)
XI-2-2. Requirements of clinical trial sites
XI-3. GCP Inspection
XI-4. Clinical Trial Data from Other Countries
XI-5. Current status of clinical trials in Japan

XII. Business and Licenses for Medical Devices
XII-1. Medical Device Manufacturer license/accreditation
XII-1-1. Domestic manufacturers
XII-1-2. Overseas manufacturers
XII-2. Medical Device Marketing Authorization Holder (MAH/DMAH) license
XII-2-1. Marketing Authorization Holder(MAH)
XII-2-2. Designated Marketing Authorization Holder(DMAH)
XII-3. Medical Device Manufacturer for Packaging, Labeling and Storage license
XII-4. Medical Device Retail/Rental Service license
XII-5. Medical Device Repair license
XII-6. Points to Remember for Overseas Companies Looking to Establish Business in Japan
XII-7. The Role of a Designated Marketing Authorization Holder (DMAH)
XII-8. J-MDC’s Independent DMAH Services Versus Those of a Distributor DMAH,br />

XIII. Sales structure for Medical Device in Japan

XIV. Legal Private Importation of Unapproved Medical Devices
XIV-1. Privately imported devices
XIV-2. Installation, training and service and maintenance

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