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Medical, Japan Medical Device Registration in Japan - April 2010 Market Research Report Code: 69861004 Price: $130.00 Instant Online Delivery (Add any three reports to your basket and the report with the lowest price is free) FREE! Table of Contents in PDF format with Page Numbers Table of Contents Executive Summary Regulatory Agencies Ministry of Health Labour and Welfare Pharmaceutical and Medical Devices Agency The Pharmaceutical Affairs and Food Sanitation Council National Institute of Health Sciences Table 1: Websites for Japanese Health Regulatory Agencies Laws and Regulations Definition of Medical Devices Registration Procedures What Risk Category is the Device? Planned Future Revisions to the Medical Device Classification System What Information is Required During the Registration Process? PMDA Consultations PMDA Review Process Table 2: Flow Chart of Approval Process for New Medical Devices Third-party Certification Standards Market Authorization Holder What Forms are used to apply for Medical Device Registration? How Much Does Registration Cost? Table 3: Examination Fees for Accreditation of Foreign Manufacturers Estimated costs for high-risk devices How Long Does the Medical Device Review Process Take? Packaging/Labeling Requirements Official Japanese Standards Clinical Trials Text of Japanese Health Laws, Regulations, and Standards on the Web Notes Related Reports: Report Title Price Medical Devices in Japan - March 2002  $75.00 Emergency Medical Care Products and Services in Japan - July 2005 $35.00 In-Vitro Diagnostics Market In Japan - June 2006 $50.00 Avian Flu Preparedness In Japan - August 2007 $65.00 Medical Device Market In Japan - September 2007 $75.00 Diagnostic Imaging Device Market In Japan - December 2007 $75.00 POCT (Point-of-Care Testing) Market in Japan - June 2009 $95.00 Medical Technology Market in Japan - December 2009 $115.00 Medical Device Reimbursement in Japan - April 2010 $100.00 Remote Medical Systems Market in Northern Japan - December 2010 $85.00 Medical Capital Equipment Market in Japan - July 2011 $90.00

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