Approval process for

Medical related products in Japan

Jun.18th.2009 　

Sceti Medical Labo K.K.

M.Ohkoshi

RequirementsRequirements

Establishment of the company in JapanEstablishment of the company in Japan ①①Marketing Business license Marketing Business license ②②Accreditation of Foreign ManufacturersAccreditation of Foreign Manufacturers ③③Products approvalProducts approval ④④Manufacturer licenseManufacturer license ⑤⑤Repair licenseRepair license

You will be approved for sale a Diagnostics/ Medical You will be approved for sale a Diagnostics/ Medical devices when you passed above colored 4 points.devices when you passed above colored 4 points.

①①Requirement for Marketing Requirement for Marketing Business license for 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

①Application form of accreditation as a foreign manufacturer of Medical Devices②Audit request form of accreditation as a foreign manufacturer of Medical Devices③Responsibility Matrix (Organization chart)④Self-Declaration⑤Career history of Manufacturing Manager⑥Manufacturing process management, Quality control process management⑦Product list for export⑧Manufacturing Flow chart⑨Brief description of the manufacturing plant and facilities in the plant⑩Plane figure of manufacturing facilities⑪List of Manufacturing equipment⑫List of test and measurement⑬GMP self-check sheet⑭Copy of the marketing license/ manufacturer license that were issued by the government of the country⑮Top plant view

②Required documents for Accreditation of Foreign Manufacturers

③Classification of Medical Devices in Japan

ClassⅠClassⅠ　　　　 Low Risk to patients even in caseLow Risk to patients even in case　　　　　 　　　　　　　　 　　　 of troubleof trouble 　（　（ X-ray film X-ray film etcetc)) ClassⅡClassⅡ　　　　 Relatively Low Risk toRelatively Low Risk to 　　 patients patients 　　　　　　　　　　　　　　　　　　 even in case of troubleeven in case of trouble 　（　（ MRI MRI

etcetc)) ClassⅢClassⅢ　　　　 Relatively High Risk to patients inRelatively High Risk to patients in　　　　　　　　　　　　　　　　　　 case of troublecase of trouble 　（　（ Dialyzer Dialyzer etcetc)) ClassⅣ ClassⅣ 　　　　 High Risk to patients in case of High Risk to patients in case of 　　　　　　　　　　　　　　　　　　 trouble, leading to the crisis of trouble, leading to the crisis of

lifelife　　　　　　　　　（　　　　　　　　　（ Pacemaker Pacemaker etcetc))

④④Manufacturer licensorManufacturer licensor

Quality controlQuality control Labeling & PackagingLabeling & Packaging StorageStorage ShipmentShipment Complaint investigationComplaint investigation

Required : responsibility engineer and QMS (Quality Management system) organization,

Manufacturer will perform :

Relation between Business license Relation between Business license and manufacture licenseand manufacture license

Marketing Business license holder

Manufacturer license holderunder Marketing Business license holder’s

instruction 　 Manufacturer / QC / stock / Shipment

Sell toSell to the Market

Marketing authorization Marketing authorization holderholder

QMS QMS organizationorganization

import

⑤ Requirement for Repair licenseRequirement 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 SiteSceti medical Labo K.K. Sakura Site

　　　　　　

Location( sakura Industry zone )Location( sakura Industry zone ) 　　　　　　　　　　　　 20Km from Narita Air Port20Km from Narita Air Port　　　　 40Km from Tokyo Downtown40Km from Tokyo Downtown

Laboratory (site 10,000m2)Laboratory (site 10,000m2) 　　　　　　　　　　　　　　　　　　 Building 2,000m2Building 2,000m2　　　　 Radioactive control area 700mRadioactive control area 700m22

SMLSML　　 LICENSESLICENSESRadioisotopesRadioisotopes 　　　　　　・ Sales license 　・Handling license

PharmaceuticalsPharmaceuticals 　 ・ Marketing business license ・ Manufacturing license ・ Wholesaler license

Medical device Medical device ・ Marketing license ・ Manufacturing license ・ Highly controlled Medical Devices retail ＆ rental license ・ Repair license

Other licenses Other licenses ・・ Poisonous ＆ Deleterious substances 　　　　　　　　　　　　　　　　　　　　　　 import / marketing license

Relation between Relation between Foreign Manufacturer Foreign Manufacturer

and and Sceti Medical LaboSceti Medical Labo

Marketing Business license holder

Manufacturer license holder

YouYou

Sceti Medical Labo

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