Japan medical device market and regulatory report

Japan Medical Device Market and Regulatory Report 2012

Version2.1
By Kunihiko Mitsuda
Published by Japan MDC

Overview

"The Japan Medical Device Market and Regulatory Report" 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.

You can purchase this 64-page report for JPY60,000-.

Table of Contents (Tables and Figures)

I. Introduction and Summary
Objectives
Opportunities
Table1: Trends of Japanese life-span
Regulatory environment

II. Japan’s Medical Devices Market Environment
II-1. Market opportunities in Japan
Table 2: Trends in the medical device market in Japan
Table 3: Category breakdown of the Japanese medical device Market
Table 4: Snapshot of Japanese mortality by cause (2010)
Table 5: Trends in Japanese mortality by cause (2010)

III. Japan’s Pharmaceutical Affairs Law (PAL)
III-1. Medical device approval and certification in Japan

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
Fig. 1: Medical device classifications and application categories

VI. Japan’s Registration Process
VI-1. Registration steps for overseas manufacturers
Fig. 2: Registration and process

VII. Requirements for Product Approval (referred to as shonin in Japanese)
VII-1. Procedural flow
Fig. 3: Procedural flow for new medical device applications
VII-2. Application categories for medical devices
Table 6: Medical device application categories
VII-3. Approval standards for medical devices
Table 7: List of Approval Standards (as of September 2011)
VII-4. Key factors in determining the necessity of clinical trial data
VII-5. Completion of application documents

VIII. Requirements for Certification (referred to as ninsho in Japanese)
VIII-1. Flow of certification procedure
Fig. 4: Flow of certification submission procedure
Table 8: List of RCBs (Registered Certification Bodies)
VIII-2. Requirements for certification submission

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
Table 9: GMP/QMS audits before and after approval/certification
Table 10: GMP/QMS auditing authorities

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
Table 11: Summary of medical device GCP
Fig. 5: Framework of medical device GCP
Fig. 6: Flow of clinical trial procedure
XI-3. GCP Inspection
Fig. 7: GCP inspection overview
XI-4. Clinical Trial Data from Other Countries
Table 12: Number of medical device approvals with clinical data
XI-5. Current status of clinical trials in Japan

XII. Business and Licenses for Medical Devices
Fig 8: In case of MAH (Marketing Authorization Holder) company is applicant
Fig 9: In case of overseas manufacturer is applicant
XII-1. Medical Device Manufacturer license/accreditation
XII-1-1. Domestic manufacturers
Table 13: Medical Device Manufacturer license
XII-1-2. Overseas manufacturers
Fig. 10: Procedural flow for foreign manufacturer accreditation
XII-2. Medical Device Marketing Authorization Holder (MAH/DMAH) license
XII-2-1. Marketing Authorization Holder(MAH)
Table 14: MAH classifications
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
Table 15: Medical device repairer categories
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)
Fig.11: Relations of each person in charges in the local
XII-8. J-MDC’s Independent DMAH Services Versus Those of a Distributor DMAH,br />

XIII. Sales structure for Medical Device in Japan
Fig.12: Flow of distribution
Fig.13: Regulation of the flow of distribution

XIV. Legal Private Importation of Unapproved Medical Devices
XIV-1.Privately imported devices
Fig.14: Private import support Malfeasance 1
Fig.15: Private import support Malfeasance 2
Fig.16: Private import support Lawful behavior
XIV-2. Installation, training and service and maintenance