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 of life （ Pacemaker etc)
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 Medical device
Other licenses
・ Marketing business license ・ Manufacturing license ・ Wholesaler license ・ Marketing license ・ Manufacturing license ・ Highly controlled Medical Devices retail ＆ rental license ・ Repair license
・ 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
Merci pour votre intérêt