Services by KBD to the customers
Medical Device Marketing Authorization Holder (MAH),
Designated Marketing Authorization Holder (D-MAH)
& Manufacturing(Storage)Holder to perform the following service.
Regulatory affairs consulting
1. Development strategy planning & Regulatory affairs consulting for medical devices
and In vitro diagnostics, quasi-drugs, regenerative medicine products, etc.
2. Sales support for foods with functional claims, etc. (including HACCAP)
3. Seminar support on the Regulatory Affairs Law, Application dossier, STED, etc.
4. Practical training support for creating license application forms
We will perform submission and registration work on behalf of overseas medical
device manufacturers aiming to enter the Japanese market.
-- Type 3 medical device manufacturing and sales license number：28B3X10031--
1. Submission for License (notification) to PMDA / MHLW in Japan
(Foreign manufacturers can directly submit manufacturing and sales notifications)
2. Foreign manufacturing industry registration
3. Actions for QMS / GVP
4. Ministry of Health, Labor and Welfare / PMDA / Prefectural office correspondence
Medical device warehouse (storage)
(Specially controlled medical devices, Controlled medical devices, General medical devices)
-- Medical device manufacturing industry registration number ：28BZ200196 --
1. Temporary storage of imported medical device
2. Our warehouse can be used for packaging, labeling and storage of your medical
Other services to the customers
Regulatory support for Merger(M&A)
Marketing assessment & Feasibility Study
Assistance with Japanese distribution & Wear house control
Assistance with QC inspection, Regulatory labeling, Pamphlet planning
Technical translation of Scientific papers, IFU and Package insert