Selling and lending medical equipment

Updated: July 2026, 8

Is a license required to sell or rent medical equipment?

If the medical devices handled by the medical device sales or rental business fall under the category of highly controlled medical devices, specified maintenance controlled medical devices, or controlled medical devices, a permit or notification is required for each business office to the governor of the location of the business office. It becomes.

What is a highly controlled medical device?

The Minister of Health, Labor and Welfare has listened to the opinion of the Pharmaceutical Affairs and Food Sanitation Council as a matter that requires appropriate management as it may have a serious impact on human life and health if side effects or functional impairment occur. Medical equipment specified by

Examples include contact lenses and dialysis machines.

What is specified maintenance management medical equipment?

Medical devices that fall under the category of “controlled medical devices” or “general medical devices” that require specialized knowledge and skills for maintenance, inspection, repair, and other management.

An example is a cardiac pacemaker.

What is managed medical equipment?

This applies to managed medical devices other than specified maintenance managed medical devices.

Permit/Notification Requirements

There are roughly two types of permission/notification requirements: (1) business office and (2) business office manager.

①Sales office

●Proper lighting, ventilation, and cleanliness.

●It must be clearly separated from permanent residences and unclean areas.

●Having the necessary equipment to store handled items hygienically and safely.

Please note that this does not apply to offices that only provide medical device programs through telecommunications lines.

If the clinic conducts sales, the clinic and sales outlet/sales office should have separate entrances to prevent intersecting movement of people inside.

If you want to turn part of your clinic into a retail store, you will need to notify the public health center of any changes in the structure of your clinic.

In principle, stores cannot be located in "buildings in the name of medical corporations." This is because medical corporations cannot engage in real estate rental business.

In addition, even if the loan is free of charge, depending on the prefecture, it may be interpreted as violating the medical law when it comes to misappropriating the medical corporation's assets or providing benefits, so it is necessary to consult in advance.

②Sales office manager

Distributors or rental companies that handle controlled medical devices must submit a sales business notification for each business office to the prefectural governor where they are located, and distributors or rental businesses that handle highly controlled medical devices must receive a license for sales, etc. , a sales office manager must be established.

The requirements for office managers vary depending on the medical devices handled.

Sales office manager for highly managed medical devices

Distributors, etc. that only sell specified vision correction lenses, etc.

(1) Basics conducted by a person who has been registered with the Minister of Health, Labor and Welfare pursuant to a separate ordinance of the Ministry of Health, Labor and Welfare after engaging in work related to the sale of highly controlled medical devices, etc. (excluding program highly controlled medical devices) for one year or more Those who have completed the course

(2) Persons who have completed a course related to the sales and lending business of contact lenses for non-vision correction.

Distributors, etc. who sell and provide only program-controlled medical devices

Conducted by a person who has been registered by the Minister of Health, Labor and Welfare pursuant to a separate ordinance of the Ministry of Health, Labor and Welfare.

Those who have completed the basic course

Distributors who sell medical devices other than those listed above

(3) A person who has completed a basic course conducted by a person registered with the Minister of Health, Labor and Welfare pursuant to a separate ordinance of the Ministry of Health, Labor and Welfare after engaging in work related to the sale or lending of medical devices for three years or more.

(2) A person who is recognized by the Minister of Health, Labor and Welfare as having knowledge and experience equal to or greater than those listed in (1) above.

　　　・Person who is qualified as a doctor, dentist, or pharmacist

　　　・Person who meets the requirements for a general marketing and marketing manager for a medical device class 1 marketing and marketing business.

　　　・Person who meets the requirements for medical device manufacturing industry responsible engineer

　　　・Person who meets the requirements for a responsible engineer in the medical device repair industry

　　　・Persons who are deemed to have passed the examination prescribed by law and have been registered.

　　　・Those who have completed the "Sales Management Manager Training", a certification system for appropriate business establishments that sell medical devices, which was jointly sponsored by the Medical Device Center Foundation and the Japan Federation of Medical Instruments and Commerce Associations.

Management medical device office manager

(1) After engaging in work related to sales of highly controlled medical devices, etc. for more than one year, or work related to sales of specially controlled medical devices, etc. for more than three years (excluding some limited medical device sales work) , those who have completed the basic training course given by a person who is registered by the government.

　　　*Basic training organization

　　　　　Medical Device Center Foundation

　　　　　Japan Home Health Equipment Association

　　　　　Comprehensive Health Promotion Foundation

(2) A person who is qualified as a doctor, dentist, or pharmacist.

(3) A person who satisfies the requirements for a general manufacturing and sales manager in a class 1 medical device manufacturing and sales business.

(4) Persons who meet the requirements for a responsible engineer in the medical device manufacturing industry

(5) A person who meets the requirements for a responsible engineer in the medical device repair industry.

(6) Persons who have been registered among those who are deemed to have passed the examination stipulated by law (= deemed successful registered sellers)

(7) Co-sponsored by the Medical Device Center (Public Interest Incorporated Foundation) and the Japan Federation of Medical Instruments and Commerce Associations

　　　Persons who have completed the "Sales Management Manager Training" certification system for medical device sales appropriate business establishments

(8) A nurse or clinical laboratory technician who is in charge of operating a sample measurement room as specified in the appendix of “Guidelines for Sample Measurement Rooms”

　　　In this case, this is limited to offices that only sell medical equipment used for testing in sample measurement rooms.

Exceptions to full-time status

The manager of a highly controlled medical device sales business can be a "doctor from a neighboring clinic."

However, it is assumed that the doctor who is the manager (= director) of the clinic works full-time at the clinic, so if he also manages the medical equipment store at the same time, the requirements for the clinic manager (full-time) will be met. will be lacking

It can also be considered.

For this reason, it is necessary for both parties to maintain full-time employment.

Regarding concurrent positions

In principle, this is not allowed, but it will be allowed in exceptional cases only in the following cases.

・In cases where it is not desirable for quality control to handle the medical device at the office due to the characteristics of the medical device, or when it is difficult to handle the medical device at the office due to the large size of the medical device, etc. Cases in which the same business operator has established another business office that is a warehouse, and the business office can be managed on-site.

・If the business office only displays samples of medical devices (excluding cases where samples are used for trial use) and does not sell, lend, or give out medical devices at the business office, and can be managed on-site at the business office. case

Basic training for becoming a sales office manager in the sales and rental industry

To become a sales office manager, you need to take a basic course.
Please check the details on the website of the registered training institution registered with the Minister of Health, Labor and Welfare below.

Medical Device Center Foundation
Japan Home Health Equipment Association
Comprehensive Health Promotion Foundation

Continuous training for sales and rental business office managers

Once you become a sales office manager, you will be required to attend training every year.
Please check the details on the website of the training implementing organization that has been notified to the Minister of Health, Labor and Welfare below.

Fukuoka Prefecture Pharmaceutical Manufacturers Association, Public Interest Incorporated Association

Japan Medical Device Dealers Association

Japan Contact Lens Association　

Chamber of Commerce and Industry Tokyo Medical Device Association

Japan Home Health Equipment Association

Comprehensive Health Promotion Foundation

Japan Dental Commerce Association

Japan Medical Device Industry Association　

Japan Medical Imaging System Industry Association

Japan Pharmaceutical Association, Public Interest Incorporated Association

Japanese Ophthalmological Association, Public Interest Incorporated Association

Disqualification requirements (highly controlled medical devices only)

If the applicant (if the applicant is a corporation, this includes the officer conducting the business) falls under any of the following ① to ⑥, this will be a criterion for disqualification and permission will not be granted. there is.

(There are no disqualified personnel for managed medical devices.)

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.