Medical device manufacturing and sales license/manufacturing registration; medical device manufacturing and sales approval/certification/notification.
Updated: July 2026, 10
Applying for a medical device requires legal knowledge regarding the Pharmaceutical and Medical Device Act and specialized knowledge regarding each medical device field.
We strive to train our professional staff to keep up with ever-changing laws and regulations and industry trends, and we hope to support our clients when they lack resources.
Our company offers a wide range of services, from startup support for those looking to enter the medical device manufacturing (import) and sales industry, to specialized services for mid-sized medical device manufacturers.
We have offices in four locations across the country: Tokyo, Nagoya, and Osaka, and can provide services nationwide.
Leave the professional and complicated procedures to us!
Our support details
We handle services related to medical devices, focusing on the following services.
Medical device manufacturing and sales license ｜ Supporting applications to each prefecture
Medical device manufacturing industry registration ｜ Supporting applications to each prefecture
Foreign Manufacturer Registration | Support for applications to the Pharmaceuticals and Medical Devices Agency (PMDA, hereinafter the same) and the Ministry of Health, Labour and Welfare
Manufacturing and sales notification of medical devices | Support for filing with PMDA
Medical device certification application | Support for applications to medical device registration and certification bodies
Medical device approval application | Support for PMDA applications
QMS/GVP procedure manual creation ｜ Supporting the creation of procedure manuals required by marketing distributors and manufacturers
Medical device applicability classification survey | Investigation and consultation regarding the applicability, classification, and generic name of medical devices
Medical device approval acquisition plan ｜ Create plans and budgets to obtain approvals and certifications
Evaluation test implementation support ｜ Support for implementation of evaluation tests at external testing institutions
Client's voice
It's difficult to get approval for medical equipment: Mr. H
Thank you very much for your help.
Getting permission for medical devices is really difficult!
The teacher who takes it so casually is really cool.
If it were me, I'd be sorry if I had to make that application myself... (Sweat)
Thank you for your continued support: Mr. A
Thank you very much.
I was really nervous when I found out that I needed to get a medical device permit, but thanks to your support I was able to get the permit without any problems. I look forward to working with you.
Benefits of requesting
1. Specialist staff will assist you.
Manufacturing (importing) and selling medical devices involves many permits and licenses.
It is difficult for busy business owners to properly interpret and apply unfamiliar laws.
As legal experts, we will reduce your burden.
2. Quick and reliable response
Our motto is fast response.
We will handle your various applications quickly and reliably on your behalf.
3. Consultation is free
We offer free consultation before placing an order.
The process leading up to approval
Licensing and approval (certification) of medical devices is a two-stage process.
⑴ General medical device approval stageItinerary
⑵ General medical device approval and certification stagesItinerary
We can also assist you in obtaining a Certificate of Origin.
For those who need to obtain a Certificate of Origin when exporting.
Are you having trouble because the procedures are so complicated and you don't know where to start?
We provide support for obtaining a specific certificate of origin based on the EPA.
Why not leave the complicated procedures, from requesting origin determination to issuing certificates, to our experts?
We are providing the latest information on medical device approvals!
[Expert explains]
Latest Topics in Medical Device Approvals
Video seminar
Chinese
English
(How to expand medical device business to Japan DMAH)
(Requirements for medical device license in Japan)
Click here for Youtube channel
Remuneration
| Support content | Remuneration amount (tax included) |
|---|---|
| New/renewal application for Type 3 medical device manufacturing and sales business license (Compatible with QMS system ministerial ordinance) | From 440,000 yen |
| Type 2 Medical Device Manufacturing and Sales Business License New/Renewal Application (Compatible with QMS system ministerial ordinance) | From 495,000 yen |
| First-class medical device manufacturing and sales business license new/renewal application (Compatible with QMS system ministerial ordinance) | From 550,000 yen |
| QMS construction | From 330,000 yen |
| Medical device manufacturer registration New registration application | From 165,000 yen |
| Medical device manufacturer registration renewal registration application | From 110,000 yen |
| Foreign Manufacturer Registration New Registration Application | From 165,000 yen |
| Foreign manufacturer registration renewal application | From 110,000 yen |
| Medical device manufacturing and sales notification (class I) | From 110,000 yen |
| Application for medical device manufacturing and sales certification (Class II) | Request for consultation |
| Medical device manufacturing and marketing approval application (Class III, Class IV) | Request for consultation |
| Medical device import notification | From 33,000 yen |
| Highly controlled medical devices (specified maintenance-controlled medical devices), etc. Sales and rental business: New license application | From 110,000 yen |
Nationwide Support
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
