Distributor in ELI) 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 I-JL.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 Device. Although Classification of 2000 MDs were classified under Old PAL, 4000 MDs have been MDs and defined based on GMDN and classified. into 4 classes under Requirements New PAL, so many devices are newly included as MD and for Marketing about 200 MDs were changed from Class Ito higher classes, Clearance so called Class-Up MDs.MDs without JIS shall comply with Essential Principles and be applied to PMDA EIJ Annex 8 Medical Device Classification Class l, lla,llb, Ill Class l: Annex 7 Technical File of the MD, Declaration of Conformity by the manufacturer and CE Marking.Serialized MD and measuring MD must be certified by NB Classlla : Annex 7 + Annex 2 or (Annex 4 or 5 or 6) Certification for Full Quality System (ISO 13485) of the manufacturer by NB.Technical File of the MD to show compliance with Essential Requirements and inspection by NB 3. Declaration of Conformity by the manufacturer 4. CE Marking US 5862 – 892 Medical Device Classification : Class General Controls: Common controls for all medical devices, such as Initial Registration of Device Establishment nd Initial Importers, Device listing, GMP/QSR etc Class’: X-ray tubes, Vacuum Tubes, etc 510(k) (Pre-market Notification) is not required except specific devices.Classll: Substantial equivalence to other products (Predicate Device) in commercial distribution, such as Diagnostic X-ray system, Ultrasound, CT, MRI, EKG etc 510(k) submission needs the device name, the establishment registration number, the class, action taken to comply with the requirements of the act for performance standard, proposed labels, labeling and documents indicating the device is substantially equivalent to predicate devices . For medical device contained Software, manufacturers must submit the documents of the Software including Risk Analysis and Verification ; Validation Data.Class Ill (Highly Controlled Medical Device : Malfunction cause substantial effect on subjects) : Dialyzer, Radio-therapy system, Respirator, etc MDs shall comply with Essential Principles and be applied to PMDA. MDs with Approval Standard (35 Std. ) shall comply with the standard and Essential Principles Depending on the intended use and materials Bio-compatibility test, Sterilization Validation and/or Clinical Study are required. Class 11b :Diagnostic X-ray, CT, etc. : Annex 7 + Annex 2 or (Annex 3 + 4 or 5 or 6) 1.Certification for Full Quality System (ISO 13485) of the manufacturer by NB 2. Technical File of MD to show compliance with Essential Requirements and inspection by NB 3. Declaration of Conformity of the MD by the manufacturer with Technical File 4. CE Marking MDC Japan 2 Japan Classification Class IV (Highly Controlled Medical Device : Invasive Device and of which malfunction may cause life threatening effects): Requirements Implantable pace maker, stent etc. shall comply with for Marketing Essential Principles and be pplied to PMDA.Clearance New MDs are required GLP (Good Laboratory Practice, Pre-Clinical tests) and Clinical Study based on GCP Notice “Remark points on Application for Marketing Approval for Medical Devices” (No. 0216001, dated Feb. 16. 2005) Attachment 1 shows the list of example of Medical Devices required Clinical Study Time scale to Class II: get Marketing MDs with Certification Standard OIS) shall be reviewed and Clearance QMS of the manufacturer shall be audited by Third Party Certification Body.