2. 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.
3. 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
4. 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
5. 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
7. 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
8. ⑤ Requirement for Repair license
responsibility engineer
-3 years experience for repair works/manufacturer work
-License should be obtained for 9 categories
9. Sceti medical Labo K.K. Sakura Site
Location( sakura Industry zone )
20Km from Narita Air Port
40Km from Tokyo Downtown
Laboratory (site 10,000m2)