Approval process for Medical related products in Japan, Sceti Medical Lab
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Transcript of 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
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 holder
under 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 LICENSESLICENSES
RadioisotopesRadioisotopes ・ 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
Merci pour votre intérêtMerci pour votre intérêt