Import and sell medical equipment

Updated: July 2026, 2

How to import and sell medical equipment

In order to import medical devices manufactured in a foreign country and sell them in Japan, the importing company must obtain a manufacturing and sales business license and medical device manufacturing business registration, and the foreign manufacturing site must also register as a foreign manufacturer. must be received.

Registration of foreign manufacturers

Even if you have obtained a marketing license or manufacturing registration in Japan, if you have not registered as a foreign manufacturer, you will not be able to approve, certify, or notify the device as a medical device, and you will not be able to sell the device.


For foreign manufacturer registration, the applicant is the foreign manufacturer who wishes to receive registration, but as a general rule, the registration procedure is carried out on behalf of the Japanese manufacturer who imports and sells the medical device being manufactured. is.


Foreign manufacturer registration is a registration granted to foreign manufacturers, so it is not tied to individual medical devices, and if you have this registration, you can do business with multiple manufacturers and distributors in Japan. It becomes.


The registration period is 5 years and must be renewed if continued.

License for medical device manufacturing and sales business

After importing medical devices manufactured overseas, the medical device manufacturing and sales industry is responsible for distributing the medical devices on the market by selling, lending, and giving them to distributors, etc. Masu. This also applies to the provision of programmed medical devices via telecommunications lines.

Imported medical devices can only be sold, lent, or given to distributors or lenders, and cannot be sold to clinics or general consumers with this license.

Types of manufacturing and sales licenses

Manufacturing and sales license requirements

For details on license requirements for manufacturing and sales businesses, please check the "Requirements for manufacturing and sales licenses" page.

Registration of medical device manufacturing industry

A medical device manufacturing and sales license alone does not allow you to import medical devices manufactured overseas. To import medical devices and store them in Japan, you must be registered as a medical device manufacturer.

Registration for medical device manufacturing must be done for each manufacturing facility, not for each company.

Medical device manufacturing industry registration requirements

For registration requirements for manufacturing businesses, please see the "Requirements for Manufacturing and Sales Licenses" page.

Medical device item procedures

In order to distribute individual medical devices on the market, it is necessary to obtain the permission and registration mentioned above and then complete the procedures for each medical device. Medical devices are classified into classes, and procedures must be followed accordingly. 

Medical device import agent introduction

At Support Administrative Scrivener Corporation, we introduce companies that have already obtained licenses for manufacturing/selling/manufacturing to those who have difficulty obtaining licenses for manufacturing/selling/manufacturing on their own, and through these companies, we can sell medical devices in Japan. We also propose a business scheme for importing and selling.

In order to obtain permits, a person with an educational background or experience is required, as well as a large number of records related to manufacturing, sales, and manufacturing, which requires considerable costs for maintenance and management.

If you have found a good medical device overseas, but think it is too risky to hire a person in charge and enter the market, import agency is also an option.

If you are considering importing medical equipment, please feel free to contact us.

For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.

At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.

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.

Our dedicated staff handles cases nationwide.