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 F3：Medical Device & Cosmetic Competent Authority of each Member States Notified Body (NB) : About 70 (BSI, TUV/RH, TUV/SUD, KEMA, etc) Notified Body (NB) in Japan: BSI, TUV/RH, TUV/SUD, SGS ,etc. 90/385/EEC Active Implantable Medical Devices Directive（AIMDD） 93/42/EEC Medical Devices Directive（MDD） 98/79/EEC In Vitro Medical Devices Directive （IVDD） Essential Requirements of each Directives Harmonized Standards (EN,IEC,ISO) MEDDEV Guidance Documents : Vigilance Guidance MEDDEV 2.12-1 Rev 5 (effective from Jan..1, 2008) Food, Drug and Cosmetic Act of 1938 1976 Medical Device Amendments (MDA) 1990 Safe Medical Device Act 1997 FDA Modernization Act 2002 Medical Device User Fee and FDA Modernization 21CFR: Code of Federal Regulation, Food and Drugs §801 Labeling §807 Establishment registration and device listing for manufacturers and initial importers of devices §814 Pre-Marketing Approval (PMA) 98/47/EEC Revised Medical Devices Directive (revised in September 2007) §820 Quality System Regulation (QSR) The following contents are mainly mentioned on Many Guidelines related to CFR MDD. Recognized Consensus Standards Registration of Representative Authority (Initial Initial Registration of Device Establishment ： Distributor in EU) Manufacturer including Foreign Manufacturer and Registration of Manufacturer and List of Device Initial Importer shall be registered into FDA File. Category and Products Annual Device Listing of the manufacturer shall be provided to FDA/CDRH Number of Japanese manufacturers registered is about 350 – 400. Number of Japanese manufacturers registered is 605 as of Oct. 2007. US Population: 303 million FDA (Food & Drug Administration) CDRH (Center for Devices and Radiological Health) : about 1,000 reviewers and specialists Review of 510(k) by Third Party Accredited Bodies such as UL、TUV America, TUV/RH, BSI etc
Laws and Regulations
License and/or Registration of each type of Business
Japan IVD is included in the category of Medical...