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

Merci pour votre intérêt