Medical equipment import agency

Updated: July 2024, 9

At Support Administrative Scrivener Corporation, we provide import agency support when it is difficult to obtain the necessary permits and licenses on your own when importing medical devices from overseas.

　

Import agency makes it possible to import medical devices in a shorter period of time than if you were to prepare everything yourself.

　

Our company specializes in obtaining permits for companies, so we have clients from a variety of genres based on our past business history. From among these clients, we match companies that are considering import agency with the most suitable ones.

Flow of medical equipment import agency

The diagram above shows the flow of medical devices manufactured overseas until they are used by end users in Japan.

At Support Administrative Scrivener Corporation, we often receive consultations about import agency from people who fall under the "sellers/lending companies" in the table above.

Cases in which we arrange import agency

Cases where there are few medical equipment items handled

An example of this is when you are engaged in other business and the products you are handling fall under the category of medical devices.

　

□I import and sell miscellaneous goods and would like to import stylish massage devices from overseas.

□We sell maternity products and would like to import baby thermometers from overseas.

□I want to wholesale high-quality reading glasses from overseas to Japan.

　

This applies to companies that do not want to enter the medical device industry in earnest, but want to handle medical devices.

　

Cases of importing and selling class I medical devices

Medical devices are classified into classes I to IV by the Ministry of Health, Labor and Welfare.

For Class I medical devices, which have the lowest impact on the human body, the procedure for items is simpler than for other classifications, so the initial fees are low.

Cases in which foreign medical device manufacturers expand into Japan

An example of this would be if you are exporting medical equipment to your own country, the US, or the EU, but would like to enter Japan.

I want to enter Japan, where competition is fierce. This applies to companies that want to supply products to Japan on a trial basis, including market research.

Advantages and disadvantages of import agency

Benefits

The cost of obtaining and maintaining manufacturing and sales licenses and manufacturing registration can be reduced.

In order to import and sell medical devices, a company that has obtained a medical device manufacturing and sales business license must register the medical device and store it at a manufacturing facility that is registered as a medical device manufacturing business.

In order to obtain a manufacturing and sales business license and manufacturing business registration for your company, it is necessary to secure a manufacturing site and hire a responsible person, and it is also necessary to create a huge amount of records regarding maintenance and management.

For companies that want to handle medical devices, but are undecided on whether to increase the number of medical devices in earnest in the future, using an import agency can greatly reduce this burden.

Medical equipment can be supplied to Japan in a short period of time

By outsourcing to an import agent, you can shorten the period (2 to 4 months) required to simply obtain a manufacturing and sales business license and manufacturing business registration on your own.

In addition, the time required for procedures for medical device items can be significantly shortened by using an import agent that has established a QMS.

Drawbacks

Purchasing costs will be higher

When outsourcing import agency, the import agency will be the importer of medical devices, and your company will purchase and sell the medical devices from the import agency.

Since you will have to pay a fee to the import agent for each medical device imported, it will be more expensive than importing directly yourself.

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.

We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.