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General Medical Indicators (1): 

General Medical Indicators (1)

General Medical Indicators (2): 

General Medical Indicators (2)

Japan’s Healthcare System (1): 

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

Japan’s Healthcare System (2): 

Japan’s Healthcare System (2)

Rate of Projected Population - over 65: 

Rate of Projected Population - over 65

National Healthcare Expenditure: 

National Healthcare Expenditure Source: Ministry of Health, Labor and Welfare (MHLW)

Healthcare Reform?: 

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

Japan Medical Device Market: 

Japan Medical Device Market

Medical Device Trade BalancesBetween U.S. and Japan: 

Medical Device Trade Balances Between U.S. and Japan $US Million Source: Ministry of Health, Labor and Welfare (MHLW)

Japan Medical Device Imports: 

Japan Medical Device Imports Source: Ministry of Health, Labor and Welfare (MHLW)

Competitive Products （Japan vs U.S.）: 

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.

U.S. Medical Device Firms in Japan: 

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

Medical Device Regulation System : 

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

How to Register Your Products: 

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

Slide15: 

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)

Risk Categories of Medical Devices: 

Risk Categories of Medical Devices

Slide17: 

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

Pharmaceutical Affairs Law Revision - Key Points: 

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

Pharmaceutical Affairs Law Revision - Revision Schedule: 

Pharmaceutical Affairs Law Revision - Revision Schedule

Review of Categories and Safety Measures Concerning Medical Devices: 

Review of Categories and Safety Measures Concerning Medical Devices

New Independent Administrative Agency : 

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

Medical Device Reimbursement: 

Medical Device Reimbursement

Seriously, Japan is a tough market: 

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

Approaching the Market: 

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

Market Information in English: 

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