Approval process for Medical related products in Japan, Sceti Medical Lab

Approval process for Medical related products in Japan Jun.18th.2009 　 Sceti Medical Labo K.K. M.Ohkoshi

Requirements  Establishment of the company in Japan  ①Marketing Business license  ②Accreditation of Foreign Manufacturers  ③Products approval  ④Manufacturer license  ⑤Repair license You will be approved for sale a Diagnostics/ Medical devices when you passed above colored 4 points.

① Requirement for Marketing Business license for Medical device 　 3 　 persons are required. -General marketing manager Graduation of a science-and-engineering system 　 university -Quality assurance manager (GQP) 3 years experience for QC/QA works -Safety manager (GVP) 3 years experience for safety management works

②Required documents for Accreditation of Foreign Manufacturers ①Application form of accreditation as a foreign manufacturer of Medical Devices ②Audit request form of accreditation as a foreign manufacturer of Medical Devices ③Responsibility Matrix (Organization chart) ④Self-Declaration ⑤Career history of Manufacturing Manager ⑥Manufacturing process management, Quality control process management ⑦Product list for export ⑧Manufacturing Flow chart ⑨Brief description of the manufacturing plant and facilities in the plant ⑩Plane figure of manufacturing facilities ⑪List of Manufacturing equipment ⑫List of test and measurement ⑬GMP self-check sheet ⑭Copy of the marketing license/ manufacturer license that were issued by the government of the country ⑮Top plant view

③Classification of Medical Devices in Japan  ClassⅠ 　　 Low Risk to patients even in case 　　　　　　　　 of trouble 　（ X-ray film etc)  ClassⅡ 　　 Relatively Low Risk to 　 patients 　　　　　　　　　 even in case of trouble 　（ MRI etc)  ClassⅢ 　　 Relatively High Risk to patients in 　　　　　　　　　 case of trouble 　（ Dialyzer etc)  ClassⅣ 　　 High Risk to patients in case of 　　　　　　　　　 trouble, leading to the crisis

④ Manufacturer licensor Required : responsibility engineer and QMS (Quality Management system) organization, Manufacturer will perform :  Quality control  Labeling & Packaging  Storage  Shipment  Complaint investigation

Relation between Business license and manufacture license import Sell to the Market Marketing Business license holder Marketing authorization holder QMS organization Manufacturer license holder under Marketing Business license holder’s instruction 　 Manufacturer / QC / stock / Shipment

⑤ Requirement for Repair license 　 responsibility engineer -3 years experience for repair works/manufacturer work -License should be obtained for 9 categories

Sceti medical Labo K.K. Sakura Site 　　　 Location( sakura Industry zone ) 　　　　　　 20Km from Narita Air Port 　　 40Km from Tokyo Downtown Laboratory (site 10,000m2) 　　　　　　　

SML 　 LICENSES Radioisotopes 　　　・ Sales license 　・ Handling license Pharmaceuticals 　・ Marketing business license ・ Manufacturing license ・ Medical device Wholesaler license ・ Marketing license ・ Manufacturing license ・ Highly controlled Medical Devices retail ＆ rental license Other licenses license ・ Repair ・ Poisonous ＆ Deleterious substances 　　　　　　　　　　　　　　　　　　　　　　 import / marketing license

Relation between Foreign Manufacturer and Sceti Medical Labo Marketing Business license holder You Manufacturer license holder Sceti Medical Labo

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Approval process for Medical related products in Japan, Sceti Medical Lab

by Pôle Numérique CCI de Bordeaux on Jul 01, 2009

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