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.

Class I (General Medical Device : Malfunction causes only minor effect on human body) : X-ray film, urgical steel knife etc are required Notification only. Classll (Controlled Medical Device: Malfunction raises low possibility of life threatening effect or serious injury) : About 400 MDs with Certification Standard OIS) : X-ray, CT, Ultrasound, EKG, Endo-scope etc shall comply with the applicable standard and Essential Principles which are same to Essential Principles of GHTF and be applied to Registered Certification Body (RCB) .

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) 1. Certification for Full Quality System (ISO 13485) of the manufacturer by NB 2.


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