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JAPAN Medical Device Market Review
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JAPAN Medical Device Market Review

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  • 1. General Medical Indicators (1)
  • 2. General Medical Indicators (2)
  • 3. Japan’s Healthcare System (1) Major Characteristics Universal Healthcare Coverage (achieved in 1961) - health insurance covering the entire population Free Access - patients can freely choose doctors, clinics, hospitals Low Co-payment Rate - patient can receive necessary medical care for a small fee (patient are required to pay anywhere 10 and 30% of treatment fee) Fee-For-Service - reimbursed based on point system
  • 4. Japan’s Healthcare System (2)
  • 5. Rate of Projected Population - over 65
  • 6. National Healthcare Expenditure Source: Ministry of Health, Labor and Welfare (MHLW)
  • 7. Healthcare Reform?
    • Past efforts included: - cut reimbursement rates (biannually since 1965) - established a separate insurance system for elderly (1984) - raised co-payment for the elderly (1997) - raised co-payment for ordinary salaried workers (1997) - established a new long-term care insurance system (2000)
    • Recent efforts (2002) included - cut reimbursement rates * first time cut on doctor’s technical fee * introduction of foreign reference price on medical devices - raised co-payment for the elderly - raised co-payment for ordinary salaried workers
  • 8. Japan Medical Device Market
  • 9. Medical Device Trade Balances Between U.S. and Japan $US Million Source: Ministry of Health, Labor and Welfare (MHLW)
  • 10. Japan Medical Device Imports Source: Ministry of Health, Labor and Welfare (MHLW)
  • 11. Competitive Products ( Japan vs U.S. )
    • Imaging Diagnostic equipment
    • Therapeutic and Surgical Equipment
    • Biophenomena Measuring and Monitoring Systems
    • Home Therapeutic Equipment
    • Others (Dialyzers, Endoscopes, Hemodialysis Apparatus, etc.)
    • Pacemakers
    • Advanced Interventional Cardiology Products such as stents
    • Orthopedic Implants
    • Laser Surgical Equipment
    • Cardiac Valve Prothesis
    • Others (MRI, CT, etc.)
    Japan U.S.
  • 12. U.S. Medical Device Firms in Japan
    • 3M Healthcare
    • Allergan
    • Bausch & Lomb
    • Baxter
    • Boston Scientific
    • Edwards Lifesciences
    • General Electric (GE)
    • Guidant
    • Johnson & Johnson
    • Kodak
    • Medtronic
    • St. Jude Medical
    American Chamber of Commerce in Japan (ACCJ), Medial Device Subcommittee has 46 member firms
  • 13. Medical Device Regulation System
    • Japanese Law
    • Pharmaceutical Affairs Law (PAL) ----- enforced by the Ministry of Health, Labor and Welfare (MHLW).
    • Necessary Governmental Authorizations
    • Manufacturing (or import) approval (" Shonin ") which guarantees the safety and efficacy of the device. (approx. 2,500-3,000 submissions per year)
    • Manufacturing ( or import) license (" Kyoka ") of a device, which the Japanese manufacturer and importer hold. (in 2002: manufacturing license - 2,709 / import license - 1,282)
    • Reimbursement listing approval
  • 14. How to Register Your Products
    • Pros
    • Simple
    • Less expensive
    • No direct involvement with the Japanese authorities
    • Cons
    • The manufacturer often is limited to one importer
    • Change of importer forces the manufacturer to reapply for shonin from the beginning
    • Dependency on the importer increases
    • Pros
    • Option to work with multiple importers who may have different strenghts
    • No reapplication for shonin upon change of importer
    • The ability to focus fully on marketing your product
    • Cons
    • Expensive
    Ask Your Importer to Apply Use In-country Care Taker
  • 15. Application Categories (1) Devices which do not require approval (2) “Me-too Devices” which are equivalent to already-approved devices in Japan (Time Clock: 4 months) (3) “Improved Devices” which do not have new characteristics as much as the devices to be reexamined but are not substantially equivalent to already-approved devices in Japan (Time Clock: 12 months) (4) “New Devices” which are different in use, function or technology from already-approved devices in Japan (Time Clock: 12 months)
  • 16. Risk Categories of Medical Devices
  • 17. New Device Submission to Prefecural Government Evaluation and Licensing Div., MHLW Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) Me-too Device Improved Device Evaluation by PMDEC Evaluation by JAAME Presentation Presentation Expert Discussion Expert Discussion Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) Equivalency Investigation Evaluation and Licensing Div., MHLW PAFCS Evaluation and Licensing Div., MHLW Prefecural Government Approval
  • 18. Pharmaceutical Affairs Law Revision - Key Points (1) review of the approval system and enhancement of past marketing safety measures * Introduction of a classification system corresponding to the risk of medical devices - three categories by risk to the human body (extremely low, low and high) * A third party certification system for low risk medical devices (2) review of the safety measures regarding medical devices; and (3) enhancement of safety measures for biological products
  • 19. Pharmaceutical Affairs Law Revision - Revision Schedule
  • 20. Review of Categories and Safety Measures Concerning M edical D evice s
  • 21. New Independent Administrative Agency Drug Manufacturers Medical Device Manufacturers JAAME Medical devices’ equivalency investigation PMDEC Review of drugs and medical devices OPSR Drug’s equivalency investigation. Clinical trial consultation. Reliability inspections. GCP, GLP and GPMSP inspections MHLW Council Report of review results Consultation Recommendation Inquiry, instruction and answer Inquiry, instruction and answer Application Approval Current System Proposed New System Drug and Medical Device Manufacturers New Independent Administrative Institution Review of drugs and medical devices (including clinical trial consultation and inspections) MHLW Council Consultation Recommendation Report of review results Application Inquiry, instruction and answer Approval Certification by a third party for low-risk medical devices
  • 22. Medical Device Reimbursement
  • 23. Seriously, Japan is a tough market
    • Cost contamination pressure
    • Over-regulation
    • High-costs of doing business
    • Protectionism
    • Unique and complex market culture
    • Competitive Japanese firms
  • 24. Approaching the Market
    • Trade Shows - Modern Hospital Show - Hospex - Japan Dental Show - and more
    • Academic Conference and Exhibition
    • Healthcare Consultants
    • The U.S. Commercial Service Programs
  • 25. Market Information in English
    • Our market research reports http://www.usatrade.gov
    • Japan External Trade Organization's (JETRO) http://www.jetro.go.jp
    • Japan Pharmaceutical Manufacturers Association (JPMA) http://www.jpma.or.jp
    • Ministry of Health, Labor and Welfare (MHLW) http://www.mhlw.go.jp/english/index.html
    • Japan Association for the Advancement of Medical Equipment (JAAME) http://www.jaame.or.jp/english/index.html