repair medical equipment
Updated: July 2025, 7
Medical device repair business is a business that restores malfunctioning, damaged, deteriorated, etc. parts of medical equipment to its original state and function (including replacement of such parts).
Even if there is no breakdown, disassembling and inspecting the equipment and replacing deteriorated parts as necessary is included in the repair business.
Maintenance inspections such as cleaning, calibration, and replacement of consumable parts are not included in repairs, so a repair business permit is not required.
If a medical device manufacturer repairs medical devices that it manufactures, it does not need a repair business license.
Permission is not required if you only introduce a repair company, but if you contract with a medical institution to repair the medical device by outsourcing it to another repair company, you may be required to obtain a license for the repaired medical device. A repair business license is required as the company is responsible for safety, etc.
Anyone wishing to carry out repairs as a business must obtain a permit for each business establishment.
| When permission is required | When permission is not required |
| ・Take home medical equipment (other than products manufactured by our company) When repairing. ・Medical equipment (other than self-manufactured products) to medical institutions, etc. If you are traveling for repairs. ・Sales of medical equipment (other than in-house manufactured products) with medical institutions, etc. When making a contract for repair. (If the responsibility for the repair falls on the repair company.) | ・Medical device manufacturers (design or final product storage only) medical devices manufactured by If the manufacturer performs the repair. ・Cleaning, calibration, and consumable parts When performing only maintenance inspections such as replacement. ・When the act is only to introduce a repair company. |
Repair classification
Repair categories are divided into nine categories, from category 1 to category 9.
Furthermore, the nine categories are divided into two: "Medical devices requiring specified maintenance (special control)" and "Medical devices other than those requiring specified maintenance (non-special control)."
Even if you have a special classification permit, you cannot repair medical equipment that falls under the same classification as a non-special jurisdiction, and you will need to obtain permission for both of the same classification.
Special maintenance management medical equipment
Special category 1: Imaging diagnostic system related
Special category 2: Biological phenomenon measurement/monitoring systems related
Special category 3: Treatment/facility equipment related
Special Division 4: Artificial organs related
Special category 5: Optical equipment related
Special category 6: Physical therapy equipment related
Special category 7: Dental equipment related
Special Division 8: Laboratory testing equipment related
Special category 9: Steel instruments/home medical equipment related
*Currently, there are no applicable items.
Medical devices other than specified maintenance management medical devices
Non-Special Category 1: Image diagnosis system related
Non-special 2nd category: Biological phenomenon measurement/monitoring system-related stem-related
Non-Special Category 3: Treatment/facility equipment related
Non-special 4th category: Artificial organ related
Non-Special Category 5: Optical equipment related
Non-Specialized Category 6: Physical therapy equipment related
Non-Specialized Category 7: Dental equipment related
Non-Specialized Category 8: Laboratory testing equipment related
Non-Specialized Category 9: Steel instruments/home medical equipment related
Repair business permit requirements
To obtain a repair business permit, you must meet the following three criteria.
① The equipment used for repair work must comply with the Regulations for Structures and Facilities of Pharmacies, etc.
②The applicant (for corporations, including the officers conducting their business) does not fall under the disqualification clause.
③ Appointment of a responsible engineer
① The equipment used for repair work must comply with the Regulations for Structures and Facilities of Pharmacies, etc.
Establishments that conduct repair work are required to comply with the following Regulations for Structures and Facilities of Pharmacies, etc. (Ministry of Health and Welfare Ordinance No. 36 of February 2, 1).
| 1 | Must have the necessary equipment to store component parts and repaired medical devices hygienically and safely. |
| 2 | Depending on the type of medical device to be repaired, equipment and equipment necessary for testing and inspection of component parts, etc. and the medical device being repaired shall be provided. However, this shall not apply if the relevant testing and testing is carried out at the manufacturer's own risk using other testing and testing equipment of the manufacturer or other testing and testing institutions, and when it is deemed that there will be no hindrance. |
| 3 | Be equipped with the necessary equipment and equipment to carry out repairs. |
| 4 | The location where repairs are performed must comply with the following requirements. (a) Adequate daylighting, lighting, and ventilation, and cleanliness. (b) It must be clearly separated from places where people regularly live and places that are unclean. (c) It must have an area that does not hinder the work. (d) Must have dust-proof, moisture-proof, insect-proof, and equipment for such prevention. However, this does not apply if it is determined that there is no problem with the medical device being repaired. (e) The floor shall be made of board, concrete, or something similar. However, this does not apply if it is deemed unavoidable due to the nature of the work due to the medical device being repaired. (f) Equipped with equipment or equipment necessary for the treatment of wastewater and waste. |
| 5 | The workbench provided in the workroom shall be one that does not hinder the smooth and appropriate work. |
②The applicant (for corporations, including the officers conducting their business) does not fall under the disqualification clause.
If the following disqualification reasons listed in Article 5, Item 3 of the Pharmaceutical and Medical Device Act apply, a license cannot be obtained.
| Lee | A person whose license has been revoked pursuant to the provisions of Article 75, Paragraph 1, and for which three years have not yet elapsed since the date of revocation. |
| Russia | A person whose registration has been canceled pursuant to the provisions of Article 75-2, Paragraph 1, and for whom three years have not yet elapsed since the date of cancellation. |
| Ha | A person who has been sentenced to imprisonment with work or a severer punishment and for whom three years have not yet passed since the execution of the sentence has been completed or the person is no longer subject to the sentence. |
| D | In addition to those who fall under (a) to (c), acts of violation of this law, the Narcotics and Psychotropic Substances Control Act, the Poisonous and Deleterious Substances Control Act, and other laws and regulations related to pharmaceutical affairs specified by cabinet order or dispositions based thereon. Those for whom two years have not passed since the date of |
| ホ | Adult wards or addicts to narcotics, cannabis, opium or stimulants |
| F | A person specified by Ordinance of the Ministry of Health, Labor and Welfare as a person who is unable to properly perform medical device repair work due to a physical or mental disability. |
③ Appointment of a responsible engineer
Repair company that repairs specified maintenance management medical devices
A person who has completed a basic course and a specialized course conducted by a person registered with the Minister of Health, Labor and Welfare after engaging in work related to the repair of medical devices for three years or more (Article 188, Paragraph 1, Item 1, A of the Enforcement Regulations)
A person who is recognized by the Minister of Health, Labor and Welfare as having knowledge and experience equivalent to or higher than those listed in (a) (Article 188, Paragraph 1, Item 1(b) of the Enforcement Regulations)
(1) Special category 1
Participants of the Medical Radiology Equipment Inspection Technician Certification Seminar (1st to 9th) held by the Japan Imaging Medical System Industry Association
(2) Special 2nd category
Those who passed the second type ME technical ability examination conducted by the Japan EM Society (1st to 17th)
Repair companies that repair medical devices other than specified maintenance management medical devices
A person who has completed a basic course conducted by a person registered with the Minister of Health, Labor and Welfare after engaging in work related to the repair of medical equipment for three years or more (Enforcement Regulations Article 188, Paragraph 1, Item 2-a)
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.
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