Comparison of Medical Device Regulations in Japan, Eu and the Usa
Comparing Medical Device Law & Regulations of Japan, EU and US
Japan Competent Authority, Related Organization Population: 127 million Ministry of Health, Labor and Welfare( MHLW), -Pharmaceutical and Food Safety Bureau, - Office of Medical Device Control - Office of Compliance - Pharmaceutical Affairs office of each Government Prefectures - Review and Audit by Pharmaceutical and Medical Device Agency （PMDA）: about 30 specialists Registered Certification Body (RCB) :14 (JQA, TUV/RH ， TUV/SUD, BSI, UL, SGS etc) Pharmaceutical Affairs Law (PAL) New PAL promulgated in July 2002, enforced as of April 1, 2005 to harmonize with GHTF and adopt Quality Management System (QMS), and Essential Principles. PAL Enforcement Ordinance, PAL Enforcement Regulation, GQP (Good Quality Practice)，GVP (Good Vigilance Practice)，QMS (Quality Management System) and GCP (Good Clinical Practice) promulgated in July 2004 – July 2005. Many Ordinances and Notices issued up till now. Transfer of Certification or Approval (KISAI-SEIBI: June 8, 2007) for medical devices approved or notified under Old PAL must be done until the next renewal of license of MAH (2006 – March 2010) Technical Standards (JIS) for Certification (396) , Approval (35) and IVD Reagent Certification (8 groups, 366) The following Licenses are required for MD business, 1. License for Manufacturer (4,269 as of 2007) 2. Accreditation of Foreign Manufacturers (about 1,000) 3. License for Marketing Authorization Holder (MAH: 2,676) who is responsible for marketing medical devices and was Manufacturer or Importer of MDs under Old PAL. 3 controllers are required, Marketing Supervisor, Safety Control manager, Quality Assurance manager (quite unique compared with US, EU) 4. License for Retail and Rental Business of ClassⅡ- Class Ⅳ MDs and Registration for sales of ClassⅠ 5. License for Repair Business of each Technical Support Office MDC Japan April ２００8．Medical Device Consulting Japan EU Population: 493 million, 27 countries EC unit
Japan Competent Authority, Related Organization Population: 127 million Ministry of Health, Labor and Welfare( MHLW), -Pharmaceutical and Food Safety Bureau, - Office of Medical Device Control - Office of Compliance - Pharmaceutical Affairs office of each Government Prefectures - Review and Audit by Pharmaceutical and Medical Device Agency （PMDA）: about 30 specialists Registered Certification Body (RCB) :14 (JQA, TUV/RH ， TUV/SUD, BSI, UL, SGS etc) Pharmaceutical Affairs Law (PAL) New PAL promulgated in July 2002, enforced as of April 1, 2005 to harmonize with GHTF and adopt Quality Management System (QMS), and Essential Principles. PAL Enforcement Ordinance, PAL Enforcement Regulation, GQP (Good Quality Practice)，GVP (Good Vigilance Practice)，QMS (Quality Management System) and GCP (Good Clinical Practice) promulgated in July 2004 – July 2005. Many Ordinances and Notices issued up till now. Transfer of Certification or Approval (KISAI-SEIBI: June 8, 2007) for medical devices approved or notified under Old PAL must be done until the next renewal of license of MAH (2006 – March 2010) Technical Standards (JIS) for Certification (396) , Approval (35) and IVD Reagent Certification (8 groups, 366) The following Licenses are required for MD business, 1. License for Manufacturer (4,269 as of 2007) 2. Accreditation of Foreign Manufacturers (about 1,000) 3. License for Marketing Authorization Holder (MAH: 2,676) who is responsible for marketing medical devices and was Manufacturer or Importer of MDs under Old PAL. 3 controllers are required, Marketing Supervisor, Safety Control manager, Quality Assurance manager (quite unique compared with US, EU) 4. License for Retail and Rental Business of ClassⅡ- Class Ⅳ MDs and Registration for sales of ClassⅠ 5. License for Repair Business of each Technical Support Office MDC Japan April ２００8．Medical Device Consulting Japan EU Population: 493 million, 27 countries EC unit